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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7684A-003 | Other Identifier | MSD | |
| jRCT2021210025 | Registry Identifier | jRCT | |
| KEYVIBE-003 | Other Identifier | MSD | |
| PHRR230831-006054 | Registry Identifier | PHRR | |
| 2023-505362-28-00 | Registry Identifier | EU CT | |
| U1111-1291-5552 | Registry Identifier | UTN | |
| 2020-004049-35 | EudraCT Number |
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Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.
The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 05-Sep-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 58 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab/Vibostolimab | Experimental | Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year). |
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| Pembrolizumab | Active Comparator | Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab/Vibostolimab | Biological | Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Participants With PD-L1 TPS ≥50% | OS was defined as the time from randomization to death due to any cause. | Up to ~39 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS in Participants With PD-L1 TPS ≥1% | OS was defined as the time from randomization to death due to any cause. | Up to ~39 months |
| OS in Participants With PD-L1 TPS 1% to 49% | OS was defined as the time from randomization to death due to any cause. |
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Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
Has a life expectancy of at least 3 months
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Has adequate organ function
Exclusion Criteria:
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boca Raton Regional Hospital ( Site 0004) | Boca Raton | Florida | 33486 | United States | ||
| Illinois Cancer Care ( Site 0026) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Final analysis for the reported results, including participant flow, was performed on 1206 participants enrolled within the primary completion data cutoff. Analysis of the remaining 58 participants will be included in the End of Trial analysis. Per protocol, response/progression or adverse events that occurred during second course were not included in efficacy or safety outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab/Vibostolimab | Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2025 |
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| Pembrolizumab | Biological | Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). |
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| Up to ~39 months |
| Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. | Up to ~56 months |
| PFS in Participants With PD-L1 TPS ≥50% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. | Up to ~56 months |
| PFS in Participants With PD-L1 TPS 1% to 49% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. | Up to ~56 months |
| Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1% | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~56 months |
| ORR in Participants With PD-L1 TPS ≥50% | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~56 months |
| ORR in Participants With PD-L1 TPS 1% to 49% | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~56 months |
| Duration of Response (DOR) in Participants With PD-L1 TPS ≥50% | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. | Up to ~56 months |
| DOR in Participants With PD-L1 TPS 1% to 49% | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. | Up to ~56 months |
| DOR in Participants With PD-L1 TPS ≥1% | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. | Up to ~56 months |
| Change From Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Baseline and up to ~56 months |
| Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Baseline and up to ~56 months |
| Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Baseline and up to ~56 months |
| Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Baseline and up to ~56 months |
| Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Baseline and up to ~56 months |
| Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Baseline and up to ~56 months |
| Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Baseline and up to ~56 months |
| Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Baseline and up to ~56 months |
| Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Baseline and up to ~56 months |
| Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Baseline and up to ~56 months |
| Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Baseline and up to ~56 months |
| Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Baseline and up to ~56 months |
| Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing | Baseline and up to ~56 months |
| Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. | Baseline and up to ~56 months |
| Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. | Baseline and up to ~56 months |
| Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Baseline and up to ~56 months |
| Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Baseline and up to ~56 months |
| Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Baseline and up to ~56 months |
| Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49% | TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to ~56 months |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. | Up to ~56 months |
| Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. | Up to ~56 months |
| Peoria |
| Illinois |
| 61615 |
| United States |
| Mercy Research - Cancer and Hematology Center ( Site 0032) | Springfield | Missouri | 65804 | United States |
| Mercy Research - David C. Pratt Cancer Center ( Site 0025) | St Louis | Missouri | 63141 | United States |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022) | Mineola | New York | 11501 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 0013) | New York | New York | 10065 | United States |
| Fox Chase Cancer Center-Hematology/Oncology ( Site 0030) | Philadelphia | Pennsylvania | 19111 | United States |
| Hospital São Carlos-Oncocentro Ce ( Site 0208) | Fortaleza | Ceará | 60135-237 | Brazil |
| Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201) | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206) | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209) | Florianópolis | Santa Catarina | 88020-210 | Brazil |
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204) | Rio de Janeiro | 20231-050 | Brazil |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200) | São Paulo | 01246-000 | Brazil |
| Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207) | São Paulo | 04014-002 | Brazil |
| BC Cancer Victoria-Clinical Trials Unit ( Site 0107) | Victoria | British Columbia | V8R 6V5 | Canada |
| Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104) | Hamilton | Ontario | L8V 5C2 | Canada |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102) | Kingston | Ontario | K7L 2V7 | Canada |
| Lakeridge Health ( Site 0106) | Oshawa | Ontario | L1G 2B9 | Canada |
| Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava | Laval | Quebec | H7M 3L9 | Canada |
| James Lind Centro de Investigacion del Cancer ( Site 0711) | Temuco | Araucania | 4800827 | Chile |
| CIDO SpA-Oncology ( Site 0707) | Temuco | Araucania | 4810218 | Chile |
| IC La Serena Research ( Site 0710) | La Serena | Coquimbo Region | 1720430 | Chile |
| Clínica Puerto Montt ( Site 0713) | Port Montt | Los Lagos Region | 5500243 | Chile |
| Oncocentro Valdivia ( Site 0715) | Valdivia | Los Ríos Region | 5112129 | Chile |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0703) | Talca | Maule Region | 3465584 | Chile |
| Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712) | Santiago | Region M. de Santiago | 7500653 | Chile |
| Orlandi Oncologia ( Site 0700) | Santiago | Region M. de Santiago | 7500713 | Chile |
| FALP ( Site 0702) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Bradfordhill ( Site 0701) | Santiago | Region M. de Santiago | 8420383 | Chile |
| Bradford Hill Norte ( Site 0708) | Antofagasta | 1240000 | Chile |
| The First Affiliated Hospital of Anhui Medical University ( Site 2022) | Hefei | Anhui | 230000 | China |
| Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017) | Hefei | Anhui | 230036 | China |
| Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030) | Beijing | Beijing Municipality | 100021 | China |
| Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001) | Beijing | Beijing Municipality | 100142 | China |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003) | Beijing | Beijing Municipality | 100142 | China |
| Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009) | Beijing | Beijing Municipality | 100730 | China |
| Beijing Chest Hospital,Capital Medical University ( Site 2020) | Beijing | Beijing Municipality | 101149 | China |
| Chongqing Cancer Hospital-Medical Oncology ( Site 2028) | Chongqing | Chongqing Municipality | 400030 | China |
| Army Medical Center of People's Liberation Army-respiratory ( Site 2025) | Chongqing | Chongqing Municipality | 400042 | China |
| Fujian Provincial Cancer Hospital-oncology department ( Site 2023) | Fuzhou | Fujian | 350014 | China |
| Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029) | Fuzhou | Fujian | 350025 | China |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( | Guangzhou | Guangdong | 510515 | China |
| Harbin Medical University Cancer Hospital ( Site 2006) | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital ( Site 2015) | Zhengzhou | Henan | 450008 | China |
| Wuhan Union Hospital-Medical Oncology ( Site 2019) | Wuhan | Hubei | 430010 | China |
| Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026) | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital-thoracic oncology II ( Site 2013) | Changsha | Hunan | 410013 | China |
| Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016) | Yangzhou | Jiangsu | 225001 | China |
| Jilin Cancer Hospital-oncology department ( Site 2000) | Changchun | Jilin | 132000 | China |
| Tang Du Hospital ( Site 2004) | Xi'an | Shaanxi | 710038 | China |
| The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012) | Xi'an | Shaanxi | 710061 | China |
| LinYi Cancer Hospital ( Site 2034) | Linyi | Shandong | 276001 | China |
| Linyi People's Hospital-Oncology ( Site 2035) | Linyi | Shandong | China |
| Fudan University Shanghai Cancer Center ( Site 2032) | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital Sichuan University-respiratory ( Site 2018) | Chengdu | Sichuan | 610041 | China |
| Hangzhou Cancer Hospital-Medical Oncology ( Site 2039) | Hangzhou | Zhejiang | 310002 | China |
| Zhejiang Cancer Hospital-Breast Oncology ( Site 2008) | Hangzhou | Zhejiang | 310022 | China |
| The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site | Hangzhou | Zhejiang | 310052 | China |
| Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027) | Linhai | Zhejiang | 317000 | China |
| The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031) | Wenzhou | Zhejiang | 325015 | China |
| Instituto de Oncologia ( Site 2300) | Santo Domingo | Nacional | 10102 | Dominican Republic |
| CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301) | Santo Domingo | Nacional | 10104 | Dominican Republic |
| CELAN,S.A ( Site 0304) | Guatemala City | 01010 | Guatemala |
| Gastrosoluciones ( Site 0302) | Guatemala City | 01010 | Guatemala |
| INTEGRA Cancer Institute ( Site 0303) | Guatemala City | 01010 | Guatemala |
| Onco Go, S.A ( Site 0306) | Guatemala City | 01010 | Guatemala |
| Oncomedica-Guatemala ( Site 0301) | Guatemala City | 01010 | Guatemala |
| Grupo Medico Angeles ( Site 3007) | Guatemala City | 01015 | Guatemala |
| Hong Kong Integrated Oncology Centre ( Site 1301) | Central | 0000 | Hong Kong |
| Queen Mary Hospital ( Site 1303) | Hksar | Hong Kong |
| Hong Kong United Oncology Centre ( Site 1302) | Jordan | Hong Kong |
| Princess Margaret Hospital ( Site 1304) | Lai Chi Kok | 999007 | Hong Kong |
| Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207) | Gyula | Bekes County | 5700 | Hungary |
| Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201) | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205) | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Mátrai Gyógyintézet ( Site 1214) | Kékestető | Heves County | 3233 | Hungary |
| Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200) | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
| Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204) | Budapest | Pest County | 1121 | Hungary |
| Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208) | Törökbálint | Pest County | 2045 | Hungary |
| Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202) | Zalaegerszeg | Zala County | 8900 | Hungary |
| Semmelweis University-Pulmonológiai Klinika ( Site 1209) | Budapest | 1083 | Hungary |
| Artemis hospital ( Site 2401) | Gurugram | Haryana | 122001 | India |
| Tata Memorial Hospital-Medical Oncology ( Site 2404) | Mumbai | Maharashtra | 400012 | India |
| All India Institute of Medical Sciences ( Site 2403) | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Rajiv Gandhi Cancer Institute And Research Centre ( Site 2400) | New Delhi | National Capital Territory of Delhi | 110085 | India |
| National Hospital Organization Nagoya Medical Center ( Site 1920) | Nagoya | Aichi-ken | 460-0001 | Japan |
| Fujita Health University ( Site 1906) | Toyoake | Aichi-ken | 470-1192 | Japan |
| Ehime University Hospital ( Site 1911) | Tōon | Ehime | 791-0295 | Japan |
| Kurume University Hospital ( Site 1912) | Kurume | Fukuoka | 830-0011 | Japan |
| Gunma Prefectural Cancer Center ( Site 1925) | Otashi | Gunma | 373-8550 | Japan |
| National Hospital Organization Hokkaido Cancer Center ( Site 1923) | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922) | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Takarazuka City Hospital ( Site 1924) | Takarazuka | Hyōgo | 665-0827 | Japan |
| Kanagawa Cardiovascular and Respiratory Center ( Site 1921) | Yokohama | Kanagawa | 236-0051 | Japan |
| Kanagawa cancer center ( Site 1916) | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital ( Site 1900) | Sendai | Miyagi | 981-0914 | Japan |
| Niigata Cancer Center Hospital ( Site 1904) | Niigata | Niigata | 951-8566 | Japan |
| Kansai Medical University Hospital ( Site 1914) | Hirakata | Osaka | 573-1191 | Japan |
| Kindai University Hospital- Osakasayama Campus ( Site 1907) | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit | Sakai | Osaka | 591-8555 | Japan |
| Osaka Medical and Pharmaceutical University Hospital ( Site 1908) | Takatsuki | Osaka | 569-8686 | Japan |
| Shizuoka Cancer Center ( Site 1905) | Nakatogari | Shizuoka | 411-8777 | Japan |
| Tochigi Cancer Center ( Site 1927) | Utsunomiya | Tochigi | 320-0834 | Japan |
| Chiba University Hospital-Medical Oncology ( Site 1926) | Chiba | 260-8677 | Japan |
| Okayama University Hospital ( Site 1913) | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute ( Site 1915) | Osaka | 541-8567 | Japan |
| Tokushima University Hospital ( Site 1917) | Tokushima | 770-8503 | Japan |
| Juntendo University Hospital ( Site 1902) | Tokyo | 113-8431 | Japan |
| Japanese Foundation for Cancer Research ( Site 1901) | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital ( Site 1910) | Wakayama | 641-8510 | Japan |
| University Malaya Medical Centre ( Site 1504) | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan ( Site 1502) | Kuantan | Pahang | 25100 | Malaysia |
| Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503) | George Town | Pulau Pinang | 10050 | Malaysia |
| Hospital Pulau Pinang ( Site 1501) | George Town | Pulau Pinang | 10450 | Malaysia |
| National Cancer Institute ( Site 1505) | Putrajaya | Putrajaya | 62250 | Malaysia |
| Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411) | Guadalajara | Jalisco | 44680 | Mexico |
| Arké SMO S.A. de C.V. ( Site 0417) | Mexico City | Mexico City | 06700 | Mexico |
| Centro de Investigacion Clinica Chapultepec ( Site 0400) | Morelia | Michoacán | 58260 | Mexico |
| iCan Oncology Center Centro Medico AVE ( Site 0405) | Monterrey | Nuevo León | 64710 | Mexico |
| Hospital H+ Queretaro ( Site 0416) | Querétaro City | Querétaro | 76000 | Mexico |
| Medical Care and Research SA de CV ( Site 0409) | Mérida | Yucatán | 97070 | Mexico |
| Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402) | Chihuahua City | 31217 | Mexico |
| Human Science Research Trials ( Site 0406) | Mexico City | 14050 | Mexico |
| Oaxaca Site Management Organization ( Site 0403) | Oaxaca City | 68000 | Mexico |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507) | San Isidro | Lima region | 15024 | Peru |
| UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504) | Cusco | Qusqu | CUSCO 84 | Peru |
| Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508) | Lima | 15001 | Peru |
| Clínica Internacional - Sede San Borja ( Site 0506) | Lima | 15036 | Peru |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500) | Lima | 15038 | Peru |
| Hospital Militar Central Luis Arias Schereiber ( Site 0502) | Lima | 15076 | Peru |
| East Avenue Medical Center-Department of Medicine ( Site 1605) | Quezon City | National Capital Region | 1100 | Philippines |
| Veterans Memorial Medical Center-Section of Oncology ( Site 1608) | Quezon City | National Capital Region | 1100 | Philippines |
| CARDINAL SANTOS MEDICAL CENTER ( Site 1606) | San Juan City, Metro Manila | National Capital Region | 1502 | Philippines |
| Cardiomed SRL Cluj-Napoca ( Site 2201) | Cluj-Napoca | Cluj | 400015 | Romania |
| Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202) | Craiova | Dolj | 200347 | Romania |
| SC Medical Center Gral SRL ( Site 2203) | Ploieşti | Prahova | 100010 | Romania |
| Central Clinical Hospital of the Presidential Administrative Department ( Site 0802) | Moscow | Moscow | 121359 | Russia |
| Moscow Regional Oncological Dispensary ( Site 0812) | Balashikha | Moscow Oblast | 143900 | Russia |
| Hadassah Medical-Oncology department ( Site 0814) | Moscow | Moscow Oblast | 121205 | Russia |
| Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809) | Nizhny Novgorod | Nizhny Novgorod Oblast | 603081 | Russia |
| GBUZ LOKB-Oncology department #1 ( Site 0804) | Saint Petersburg | Sankt-Peterburg | 194291 | Russia |
| Republican Clinical Oncology Dispensary ( Site 0805) | Kazan' | Tatarstan, Respublika | 420029 | Russia |
| Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803) | Saint Petersburg | 197758 | Russia |
| Wits Clinical Research ( Site 0900) | Johannesburg | Gauteng | 2193 | South Africa |
| Medical Oncology Centre of Rosebank ( Site 0906) | Johannesburg | Gauteng | 2196 | South Africa |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901) | Pretoria | Gauteng | 0181 | South Africa |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902) | Sandton | Gauteng | 2196 | South Africa |
| Wits Clinical Research-Wits Clinical Research Bara ( Site 0908) | Soweto | Gauteng | 2013 | South Africa |
| The Oncology Centre ( Site 0905) | Durban | KwaZulu-Natal | 4091 | South Africa |
| Abraham Oncology ( Site 0907) | Richards Bay | KwaZulu-Natal | 3900 | South Africa |
| Cape Town Oncology Trials ( Site 0903) | Cape Town | Western Cape | 7570 | South Africa |
| National Cancer Center-Lung Cancer Center ( Site 1407) | Goyang-si | Kyonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital ( Site 1403) | Seongnam | Kyonggi-do | 13620 | South Korea |
| The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405) | Suwon | Kyonggi-do | 16247 | South Korea |
| Chungbuk National University Hospital-Internal medicine ( Site 1406) | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Seoul National University Hospital ( Site 1401) | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital ( Site 1409) | Seoul | 03181 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410) | Seoul | 03312 | South Korea |
| Severance Hospital, Yonsei University Health System ( Site 1402) | Seoul | 03722 | South Korea |
| Asan Medical Center ( Site 1400) | Seoul | 05505 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408) | Seoul | 06591 | South Korea |
| Chulalongkorn University ( Site 1802) | Bangkok | Bangkok | 10330 | Thailand |
| Ramathibodi Clinical Research Centre ( Site 1801) | Bangkok | Bangkok | 10400 | Thailand |
| Faculty of Medicine Siriraj Hospital ( Site 1800) | Bangkok | Bangkok | 10700 | Thailand |
| Erciyes University Medical Oncology Department ( Site 1007) | Talas | Kayseri | 38039 | Turkey (Türkiye) |
| Hacettepe Universitesi-oncology hospital ( Site 1001) | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1002) | Ankara | 06520 | Turkey (Türkiye) |
| Gazi Universitesi-Oncology ( Site 1003) | Ankara | 06560 | Turkey (Türkiye) |
| Acıbadem Maslak Hastanesi ( Site 1008) | Istanbul | 34457 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000) | Istanbul | 34668 | Turkey (Türkiye) |
| Samsun Medical Park Hastanesi-medical oncology ( Site 1005) | Samsun | 55200 | Turkey (Türkiye) |
| Cherkasy Regional Oncology Dispensary ( Site 1110) | Cherkassy | Cherkasy Oblast | 18009 | Ukraine |
| Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113) | Chernihiv | Chernihiv Oblast | 14029 | Ukraine |
| Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100) | Dnipro | Dnipropetrovsk Oblast | 49102 | Ukraine |
| MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104) | Kryvyi Rih | Dnipropetrovsk Oblast | 50048 | Ukraine |
| Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119) | Kharkiv | Kharkiv Oblast | 61103 | Ukraine |
| National Cancer Institute ( Site 1114) | Kyiv | Kyivska Oblast | 03022 | Ukraine |
| Vinnytsia Regional Clinical Oncological Hospital ( Site 1102) | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
| Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120) | Uzhhorod | Zakarpattia Oblast | 88000 | Ukraine |
| Oncolife LLC-day-stay department ( Site 1107) | Zaporizhzhia | Zaporizhzhia Oblast | 69059 | Ukraine |
| Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103) | Zhytomyr | Zhytomyr Oblast | 10002 | Ukraine |
| Hanoi Oncology Hospital ( Site 2502) | Hanoi | Hanoi | 100000 | Vietnam |
| K Hospital - National Cancer Hospital ( Site 2506) | Hanoi | Hanoi | 100000 | Vietnam |
| National Lung Hospital-Oncology Department ( Site 2503) | Hanoi | Hanoi | 100000 | Vietnam |
| Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 2505) | Ho Chi Minh City | 700 000 | Vietnam |
| HCMC University Medical Center-Chemotherapy Department ( Site 2501) | Ho Chi Minh City | 700000 | Vietnam |
| FG001 | Pembrolizumab | Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year). |
| Treated |
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| Received Pembrolizumab/Vibostolimab (MK-7684A) Second Course |
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| Received Pembrolizumab Second Course |
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| COMPLETED |
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| NOT COMPLETED |
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Per protocol, analysis population consisted of all participants randomized by the primary completion data cut-off.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab/Vibostolimab | Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year). |
| BG001 | Pembrolizumab | Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | Randomization of participants in the study was stratified by ECOG Performance Status. Scores are defined as follows: 0 (Fully active, able to carry on all pre-disease performance without restriction), 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), or 2 (Ambulatory & capable of all selfcare but unable to carry out any work activities, up & about more than 50% of waking hours). | Count of Participants | Participants |
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| Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline | Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Randomization of participants in the study was stratified by PD-L1 tumor proportion score (TPS) at baseline (1-49% or ≥ 50%). Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor. | Count of Participants | Participants |
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| Geographic Region | Randomization of participants in the study was stratified by geographic region of the enrolling site (East Asia vs Non-East Asia). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) in Participants With PD-L1 TPS ≥50% | OS was defined as the time from randomization to death due to any cause. | The analysis population consisted of all participants with PD-L1 TPS ≥ 50% who were randomized prior to the primary completion data cut-off. | Posted | Median | 95% Confidence Interval | Months | Up to ~39 months |
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| Secondary | OS in Participants With PD-L1 TPS ≥1% | OS was defined as the time from randomization to death due to any cause. | The analysis population consisted of all participants with PD-L1 TPS ≥ 1% who were randomized prior to the primary completion data cut-off. | Posted | Median | 95% Confidence Interval | Months | Up to ~39 months |
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| Secondary | OS in Participants With PD-L1 TPS 1% to 49% | OS was defined as the time from randomization to death due to any cause. | The analysis population consisted of all participants with PD-L1 TPS 1% to 49% who were randomized prior to the primary completion data cut-off. | Posted | Median | 95% Confidence Interval | Months | Up to ~39 months |
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| Secondary | Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Participants With PD-L1 TPS ≥50% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Participants With PD-L1 TPS 1% to 49% | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1% | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR in Participants With PD-L1 TPS ≥50% | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR in Participants With PD-L1 TPS 1% to 49% | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in Participants With PD-L1 TPS ≥50% | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR in Participants With PD-L1 TPS 1% to 49% | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR in Participants With PD-L1 TPS ≥1% | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% | Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49% | TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% | TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% | TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% | TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced One or More Adverse Events (AEs) | The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. | Not Posted | Up to ~56 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. | Not Posted | Up to ~56 months | Participants |
Up to approximately 39 months
Serious & Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. ACM & AEs reported separately for second course treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab/Vibostolimab First Course | Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. | 291 | 594 | 249 | 593 | 478 | 593 |
| EG001 | Pembrolizumab First Course | Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. | 310 | 612 | 220 | 610 | 472 | 610 |
| EG002 | Pembrolizumab/Vibostolimab Second Course | Participants who stopped pembrolizumab/vibostolimab after receiving 35 treatment cycles or participants who stopped pembrolizumab/vibostolimab after attaining a confirmed CR were eligible for a second course of pembrolizumab/vibostolimab. Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by IV infusion Q3W for up to 17 additional administrations. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Pembrolizumab Second Course | Participants who stopped pembrolizumab after receiving 35 treatment cycles or participants who stopped pembrolizumab after attaining a confirmed CR were eligible for a second course of pembrolizumab. Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 17 additional administrations. | 0 | 3 | 0 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dilated cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Retroperitoneal mass | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gallbladder rupture | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cytomegalovirus gastritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone callus excessive | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral microinfarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated myelitis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated cystitis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchus compression | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| SJS-TEN overlap | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Medical aid in dying | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jul 28, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
| ECOG = 2 |
|
| TPS 1-49% |
|
| Non-East Asia |
|
|
|
|
|