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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7684A-007 | Other Identifier | MSD | |
| KEYVIBE-007 | Other Identifier | MSD | |
| jRCT2031220098 | Registry Identifier | jRCT | |
| 2023-506074-12-00 | Registry Identifier | EU CT | |
| U1111-1293-2114 | Registry Identifier | UTN |
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The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7684A + Chemotherapy | Experimental | Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Pembrolizumab + Chemotherapy | Active Comparator | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab/Vibostolimab | Biological | Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. | Up to approximately 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in All Participants | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all randomized participants. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. | Up to approximately 29 months |
| Progression-Free Survival (PFS) |
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth Memorial Hospital-Heme Onc ( Site 0003) | Colorado Springs | Colorado | 80909 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39230120 | Derived | Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-7684A + Chemotherapy | Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
| 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 | Yes | No | No | Study Protocol | Jan 22, 2025 | Sep 22, 2025 |
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|
| Carboplatin | Drug | Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations |
|
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| Cisplatin | Drug | Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations |
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| Paclitaxel | Drug | Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations |
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| Nab-paclitaxel | Drug | Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations |
|
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| Pemetrexed | Drug | Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision |
|
|
| Pembrolizumab | Biological | Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations |
|
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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 (BICR) was planned to be presented. |
| Up to approximately 29 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with 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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by blinded independent central review (BICR) was planned to be presented. | Up to approximately 29 months |
| Duration of Response (DOR) | 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 BICR was planned to be presented. | Up to approximately 29 months |
| Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 was planned to 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 approximately 29 months |
| Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 was planned to 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 approximately 29 months |
| Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 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 approximately 29 months |
| Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Change from baseline in the score of EORTC QLQ-C30 Item 8 was planned to 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 approximately 29 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) | Change from baseline in the score of EORTC QLQ-LC13 Item 31 was planned to 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 approximately 29 months |
| Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13 | Change from baseline in the score of EORTC QLQ-LC13 Item 40 was planned to 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 approximately 29 months |
| Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 | TTD in the score of EORTC QLQ-C30 Items 29 and 30 was planned to 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. | Up to approximately 29 months |
| TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30 | TTD in the score of EORTC QLQ-C30 Items 1-5 was planned to 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. | Up to approximately 29 months |
| TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | TTD in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 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. | Up to approximately 29 months |
| TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | TTD in the score of EORTC QLQ-C30 Item 8 was planned to 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. | Up to approximately 29 months |
| TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 | TTD in the score of EORTC QLQ-LC13 Item 31 was planned to 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. | Up to approximately 29 months |
| TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | TTD in the score of EORTC QLQ-LC13 Item 40 was planned to 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. | Up to approximately 29 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 approximately 46 months |
| Number of Participants Who Discontinued Study Intervention Due to an 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 approximately 46 months |
| University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031) |
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Mayo Clinic in Florida ( Site 0022) | Jacksonville | Florida | 32224 | United States |
| Mount Sinai Hospital ( Site 0011) | Chicago | Illinois | 60608 | United States |
| University of Chicago Medical Center ( Site 0015) | Chicago | Illinois | 60637 | United States |
| New England Cancer Specialists ( Site 0008) | Scarborough | Maine | 04074 | United States |
| Cancer and Hematology Centers of Western Michigan ( Site 0002) | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic in Rochester, Minnesota ( Site 0030) | Rochester | Minnesota | 55905 | United States |
| Stony Brook University-Cancer Center ( Site 0013) | Stony Brook | New York | 11794 | United States |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012) | Lancaster | Pennsylvania | 17604 | United States |
| Charleston Oncology ( Site 0019) | Charleston | South Carolina | 29414 | United States |
| University of Virginia Cancer Center ( Site 0018) | Charlottesville | Virginia | 22903 | United States |
| Centro de Oncología e Investigación de Buenos Aires ( Site 0203) | Berazategui | Buenos Aires | B1884BBF | Argentina |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204) | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209) | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202) | Buenos Aires | Buenos Aires F.D. | C1431FWO | Argentina |
| Sanatorio Parque ( Site 0205) | Rosario | Santa Fe Province | 2000 | Argentina |
| Hospital Provincial del Centenario ( Site 0212) | Rosario | Santa Fe Province | 2002 | Argentina |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206) | La Rioja | F5300COE | Argentina |
| Klinik Penzing-2. Lungenabteilung ( Site 0702) | Vienna | State of Vienna | 1140 | Austria |
| Medizinische Universität Graz ( Site 0704) | Graz | Styria | 8036 | Austria |
| Medizinische Universitaet Innsbruck ( Site 0703) | Innsbruck | Tyrol | 6020 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705) | Linz | Upper Austria | 4020 | Austria |
| Kepler Universitätsklinikum ( Site 0707) | Linz | Upper Austria | 4021 | Austria |
| Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701) | Vienna | 1210 | Austria |
| Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403) | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405) | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Clínica de Oncologia Reichow ( Site 0407) | Blumenau | Santa Catarina | 89010-340 | Brazil |
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406) | Rio de Janeiro | 20230-130 | Brazil |
| Hospital Paulistano ( Site 0401) | São Paulo | 01321-001 | Brazil |
| James Lind Centro de Investigación del Cáncer ( Site 0502) | Temuco | Araucania | 4800827 | Chile |
| CIDO SpA-Oncology ( Site 0508) | Temuco | Araucania | 4810148 | Chile |
| Biocenter ( Site 0514) | Concepción | Biobio | 4070196 | Chile |
| FALP-UIDO ( Site 0505) | Santiago | Region M. de Santiago | 6900941 | Chile |
| Centro de Oncología de Precisión ( Site 0515) | Santiago | Region M. de Santiago | 7560908 | Chile |
| Bradfordhill ( Site 0510) | Santiago | Region M. de Santiago | 8420383 | Chile |
| ONCOCENTRO APYS-ACEREY ( Site 0503) | Viña del Mar | Valparaiso | 2520598 | Chile |
| Centro de Investigación Oncológica del Norte ( Site 0504) | Antofagasta | 1240000 | Chile |
| Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619) | Hefei | Anhui | 230036 | China |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602) | Beijing | Beijing Municipality | 100142 | China |
| Fujian Provincial Cancer Hospital-oncology department ( Site 2621) | Fuzhou | Fujian | 350014 | China |
| The First Affiliated hospital of Xiamen University ( Site 2626) | Xiamen | Fujian | 361003 | China |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( | Guangzhou | Guangdong | 510515 | China |
| Harbin Medical University Cancer Hospital-oncology of department ( Site 2604) | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital ( Site 2608) | Zhengzhou | Henan | 450000 | China |
| Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618) | Wuhan | Hubei | 430022 | China |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 2617) | Wuhan | Hubei | 430030 | China |
| Xiangya Hospital Central South University-Oncology department ( Site 2627) | Changsha | Hunan | 410008 | China |
| The Second Xiangya Hospital of Central South University ( Site 2623) | Changsha | Hunan | 410011 | China |
| Hunan Cancer Hospital ( Site 2622) | Changsha | Hunan | 410013 | China |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( | Nanjing | Jiangsu | 210000 | China |
| The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625) | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624) | Nanchang | Jiangxi | 330006 | China |
| Jilin Cancer Hospital-oncology department ( Site 2603) | Changchun | Jilin | 132000 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607) | Xi'an | Shaanxi | 710061 | China |
| Shandong Cancer Hospital-Oncology Department ( Site 2630) | Jinan | Shandong | 250117 | China |
| Fudan University Shanghai Cancer Center ( Site 2616) | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Pulmonary Hospital-Oncology Department ( Site 2601) | Shanghai | Shanghai Municipality | 200433 | China |
| Sichuan Cancer hospital ( Site 2628) | Chengdu | Sichuan | 610041 | China |
| West China Hospital of Sichuan University ( Site 2610) | Chengdu | Sichuan | 610041 | China |
| The Second People's Hospital of Yibin ( Site 2629) | Yibin | Sichuan | 644000 | China |
| Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606) | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613) | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615) | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital-Oncology ( Site 2612) | Hangzhou | Zhejiang | 310022 | China |
| The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site | Hangzhou | Zhejiang | 310052 | China |
| Fundación Colombiana de Cancerología Clínica Vida ( Site 0603) | Medellín | Antioquia | 050030 | Colombia |
| Administradora Country S.A. - Clinica del Country ( Site 0601) | Bogotá | Bogota D.C. | 110221 | Colombia |
| Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606) | Valledupar | Cesar Department | 200001 | Colombia |
| Oncomedica S.A.-Oncomedica S.A ( Site 0609) | Montería | Departamento de Córdoba | 230001 | Colombia |
| Oncologos del Occidente ( Site 0608) | Pereira | Risaralda Department | 660001 | Colombia |
| CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806) | Orléans | Centre-Val de Loire | 45067 | France |
| Centre Hospitalier d'Annecy ( Site 0807) | Epagny Metz-Tessy | Haute-Savoie | 74370 | France |
| Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th | Lille | Hauts-de-France | 59037 | France |
| Institut de Cancérologie de l'Ouest ( Site 0802) | Angers | Maine-et-Loire | 49055 | France |
| CENTRE LEON BERARD ( Site 0803) | Lyon | Rhone | 69373 | France |
| HIA Sainte Anne ( Site 0804) | Toulon | Var | 83800 Cedex 9 | France |
| Centre Hospitalier d'Avignon ( Site 0810) | Avignon | Vaucluse | 84000 | France |
| UKGM Gießen/Marburg-Medical Clinic V ( Site 0912) | Giessen | Hesse | 35392 | Germany |
| GEFOS Gesellschaft f. onkologische Studien ( Site 0909) | Dortmund | North Rhine-Westphalia | 44263 | Germany |
| Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902) | Lübeck | Schleswig-Holstein | 23538 | Germany |
| SRH Wald-Klinikum Gera ( Site 0911) | Gera | Thuringia | 07548 | Germany |
| Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913 | Berlin | 13353 | Germany |
| Rambam Health Care Campus-Oncology ( Site 1303) | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center-Oncology ( Site 1306) | Jerusalem | 9013102 | Israel |
| Meir Medical Center-oncology ( Site 1301) | Kfar Saba | 4428164 | Israel |
| Sheba Medical Center-ONCOLOGY ( Site 1302) | Ramat Gan | 5265601 | Israel |
| Sourasky Medical Center-Oncology ( Site 1305) | Tel Aviv | 6423906 | Israel |
| National Hospital Organization Shikoku Cancer Center ( Site 2414) | Matsuyama | Ehime | 791-0280 | Japan |
| Ehime University Hospital ( Site 2411) | Tōon | Ehime | 791-0295 | Japan |
| Hyogo Cancer Center-Thoracic Oncology ( Site 2409) | Akashi | Hyōgo | 673-8558 | Japan |
| Kanazawa University Hospital ( Site 2407) | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405) | Yokohama | Kanagawa | 241-8515 | Japan |
| Miyagi Cancer Center ( Site 2401) | Natori-shi | Miyagi | 981-1293 | Japan |
| Kansai Medical University Hospital ( Site 2415) | Hirakata | Osaka | 573-1191 | Japan |
| Saitama Prefectural Cancer Center ( Site 2406) | Ina-machi | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center ( Site 2408) | Nakatogari | Shizuoka | 411-8777 | Japan |
| Japanese Foundation for Cancer Research ( Site 2402) | Koto | Tokyo | 135-8550 | Japan |
| Showa University Hospital ( Site 2403) | Shinagawa | Tokyo | 1428666 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 2413) | Fukuoka | 810-8563 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 2412) | Fukuoka | 811-1395 | Japan |
| Okayama University Hospital ( Site 2410) | Okayama | 700-8558 | Japan |
| Nippon Medical School Hospital ( Site 2404) | Tokyo | 113-8603 | Japan |
| CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304) | Saltillo | Coahuila | 25279 | Mexico |
| Hospital Civil Fray Antonio Alcalde ( Site 0307) | Guadalajara | Jalisco | 44280 | Mexico |
| Arké SMO S.A. de C.V. ( Site 0301) | Mexico City | Mexico City | 06700 | Mexico |
| Alivia Clínica de Alta Especialidad ( Site 0310) | Mexico City | Mexico City | 06760 | Mexico |
| Przychodnia Lekarska KOMED ( Site 1902) | Konin | Greater Poland Voivodeship | 62-500 | Poland |
| Med-Polonia Sp. z o. o. ( Site 1909) | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908) | Warsaw | Masovian Voivodeship | 04-125 | Poland |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904) | Przemyśl | Podkarpackie Voivodeship | 37-700 | Poland |
| Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906) | Prabuty | Pomeranian Voivodeship | 82-550 | Poland |
| Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907) | Bystra | Silesian Voivodeship | 43-360 | Poland |
| Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201) | Hwasun | Jeonranamdo | 58128 | South Korea |
| Pusan National University Hospital ( Site 2205) | Busan | Pusan-Kwangyokshi | 49241 | South Korea |
| Asan Medical Center ( Site 2206) | Songpa-gu | Seoul | 05505 | South Korea |
| Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202) | Deagu | Taegu-Kwangyokshi | 41404 | South Korea |
| Chungnam national university hospital-Department of Internal Medicine ( Site 2203) | Daejeon | Taejon-Kwangyokshi | 35015 | South Korea |
| Korea University Guro Hospital-Internal Medicine ( Site 2204) | Seoul | South Korea |
| CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106) | A Coruña | La Coruna | 15006 | Spain |
| Hospital Insular de Gran Canaria-Oncology ( Site 1102) | Las Palmas de Gran Canaria | Las Palmas | 35001 | Spain |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101) | Barcelona | 08035 | Spain |
| Hospital Clinico San Carlos-Oncology Department ( Site 1107) | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103) | Seville | 41009 | Spain |
| Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105) | Zaragoza | 50009 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254) | Kaohsiung City | 807 | Taiwan |
| China Medical University Hospital ( Site 2253) | Taichung | 40447 | Taiwan |
| NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital-Oncology ( Site 2255) | Taipei | 100 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch ( Site 2251) | Taoyuan | 333 | Taiwan |
| Faculty of Medicine Siriraj Hospital ( Site 2304) | Bangkok | Bangkok | 10700 | Thailand |
| Chulabhorn Hospital ( Site 2305) | Lak Si | Bangkok | 10210 | Thailand |
| Faculty of Medicine - Khon Kaen University ( Site 2303) | Muang | Changwat Khon Kaen | 40002 | Thailand |
| Songklanagarind hospital ( Site 2302) | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301) | Chiang Mai | 50200 | Thailand |
| Acibadem Altunizade Hospital-Oncology ( Site 1207) | Üsküdar / Stanbul | Istanbul | 34662 | Turkey (Türkiye) |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208) | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe Universitesi-oncology hospital ( Site 1202) | Ankara | 06230 | Turkey (Türkiye) |
| Liv Hospital Ankara-Oncology ( Site 1205) | Ankara | 06680 | Turkey (Türkiye) |
| Ankara City Hospital ( Site 1204) | Ankara | 06800 | Turkey (Türkiye) |
| Trakya University-Medical Oncology ( Site 1203) | Edirne | 22030 | Turkey (Türkiye) |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209) | Istanbul | 34722 | Turkey (Türkiye) |
| Umraniye Training and Research Hospital-medical oncology ( Site 1206) | Istanbul | 34766 | Turkey (Türkiye) |
| Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502) | Leicester | England | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501) | London | England | SW10 9NH | United Kingdom |
| St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506) | London | London, City of | EC1A 7BE | United Kingdom |
| University College London Hospital-Cancer Clinical Trials Unit ( Site 1509) | London-Camden | London, City of | NW1 2PG | United Kingdom |
| Plain Language Summary | View source |
| FG001 | Pembrolizumab + Chemotherapy | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
| Treated |
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| Transitioned to Pembrolizumab + Chemotherapy |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-7684A + Chemotherapy | Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
| BG001 | Pembrolizumab + Chemotherapy | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
| 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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| 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 Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. | The analysis population includes all randomized participants with PD-L1 TPS≥1%. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | Overall Survival (OS) in All Participants | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all randomized participants. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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 (BICR) was planned to be presented. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned PFS data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants with 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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by blinded independent central review (BICR) was planned to be presented. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ORR data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | Duration of Response (DOR) | 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 BICR was planned to be presented. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned DOR data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned electronic patient-reported outcome (ePRO) data are unavailable. | Posted | Baseline and Up to approximately 29 months |
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| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Baseline and Up to approximately 29 months |
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| Secondary | Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Baseline and up to approximately 29 months |
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| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Change from baseline in the score of EORTC QLQ-C30 Item 8 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Baseline and Up to approximately 29 months |
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| 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) | Change from baseline in the score of EORTC QLQ-LC13 Item 31 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Baseline and Up to approximately 29 months |
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| Secondary | Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13 | Change from baseline in the score of EORTC QLQ-LC13 Item 40 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Baseline and Up to approximately 29 months |
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| Secondary | Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 | TTD in the score of EORTC QLQ-C30 Items 29 and 30 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30 | TTD in the score of EORTC QLQ-C30 Items 1-5 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | TTD in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | TTD in the score of EORTC QLQ-C30 Item 8 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 | TTD in the score of EORTC QLQ-LC13 Item 31 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Up to approximately 29 months |
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| Secondary | TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | TTD in the score of EORTC QLQ-LC13 Item 40 was planned to 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. | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | Posted | Up to approximately 29 months |
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| 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 | Jan 2027 | Up to approximately 46 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an 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 | Jan 2027 | Up to approximately 46 months | Participants |
Up to approximately 29 months
The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
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 | MK-7684A + Chemotherapy | Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. | 190 | 366 | 205 | 360 | 349 | 360 |
| EG001 | Pembrolizumab + Chemotherapy | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. | 193 | 373 | 180 | 368 | 352 | 368 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Immune-mediated myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Addison's disease | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Diabetes insipidus | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypophysitis | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypopituitarism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis ulcerative | 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 |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mesenteric artery stenosis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proctitis | 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 pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inadequate analgesia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Treatment noncompliance | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Drug-induced liver injury | 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 |
| |
| Immune-mediated hepatic disorder | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Biliary tract infection | 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 |
| |
| Campylobacter infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clonorchiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dengue fever | 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 |
| |
| Diverticulitis | 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 |
| |
| Erysipelas | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Myiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis | 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 bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | 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 |
| |
| Soft tissue infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tracheobronchitis | 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 |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Forearm 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 |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Upper limb 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 creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count 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 |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperkalaemia | 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 |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malnutrition | 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 |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic 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 |
| |
| Tumour necrosis | 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 |
| |
| Aphasia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Carotid artery stenosis | 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 |
| |
| 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 |
| |
| Encephalopathy | 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 |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Polyradiculoneuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aspiration | 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 |
| |
| 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 |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Idiopathic interstitial pneumonia | 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 |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Panniculitis | 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 |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | 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 |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | 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 |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | 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 |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight increased | 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 |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | 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 |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric 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 |
| |
| Alopecia | 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 |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
The pre-specified futility criteria were met at the futility analysis before efficacy IA, and the Sponsor decided to discontinue treatment with MK 7684A. No additional efficacy analysis will be conducted. Analyses on secondary efficacy endpoints, specifically PFS, ORR, DOR and patient-reported outcomes (PROs), will not be conducted.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2025 | Sep 22, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
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| 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 |
|
|
|
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
|
| OG001 | Pembrolizumab + Chemotherapy | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| OG001 | Pembrolizumab + Chemotherapy | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
|
| OG001 | Pembrolizumab + Chemotherapy | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|
| Pembrolizumab + Chemotherapy |
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
|