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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7684A-008 | Other Identifier | MSD | |
| KEYVIBE-008 | Other Identifier | MSD | |
| jRCT2021220008 | Registry Identifier | jRCT | |
| 2023-503517-30-00 | Registry Identifier | EU CT | |
| U1111-1287-4436 | Registry Identifier | UTN | |
| 2021-005034-42 | EudraCT Number |
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This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.
With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.
Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab/Vibostolimab | Experimental | Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve [AUC] 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
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| Atezolizumab | Active Comparator | Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab/Vibostolimab Co-Formulation | Biological | Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data. | Up to approximately 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infirmary Cancer Care ( Site 0022) | Mobile | Alabama | 36607 | United States | ||
| Los Angeles Hematology Oncology Medical Group ( Site 0006) |
| 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 | Pembrolizumab/Vibostolimab | Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve [AUC] 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2025 |
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| Saline placebo | Drug | Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1) |
|
| Etoposide | Drug | Etoposide 100 mg/m^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles |
|
| Cisplatin | Drug | Cisplatin 75 mg/m^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles. |
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| Atezolizumab | Biological | Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met. |
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| Carboplatin | Drug | Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles. |
|
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| Up to approximately 25 months |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen & Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or > upper limit of normal [ULN]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No). | Up to approximately 25 months |
| Duration of Response (DOR) | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data. | Up to approximately 25 months |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to approximately 60 months |
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to approximately 60 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) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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 60 months |
| Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related 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 60 months |
| Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related 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 60 months |
| Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer specific health-related 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 60 months |
| Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | EORTC QLQ-LC13 is a lung cancer specific health-related 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 60 months |
| Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to approximately 60 months |
| TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to approximately 60 months |
| TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to approximately 60 months |
| TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to approximately 60 months |
| TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Baseline and up to approximately 60 months |
| Los Angeles |
| California |
| 90017 |
| United States |
| VA West Los Angeles Medical Center ( Site 0004) | Los Angeles | California | 90073 | United States |
| Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) | Boca Raton | Florida | 33486 | United States |
| Fort Wayne Medical Oncology and Hematology ( Site 0013) | Fort Wayne | Indiana | 46804 | United States |
| Dana-Farber Cancer Institute ( Site 0018) | Boston | Massachusetts | 02215 | United States |
| Cancer and Hematology Centers of Western Michigan ( Site 0001) | Grand Rapids | Michigan | 49503 | United States |
| Hattiesburg Clinic Hematology/Oncology ( Site 0003) | Hattiesburg | Mississippi | 39401 | United States |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) | Lancaster | Pennsylvania | 17601 | United States |
| Blue Ridge Cancer Care ( Site 0015) | Blacksburg | Virginia | 24060 | United States |
| University of Virginia Cancer Center ( Site 0019) | Charlottesville | Virginia | 22903 | United States |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1199ABB | Argentina |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) | Buenos Aires | Buenos Aires F.D. | C1431FWO | Argentina |
| Hospital Provincial del Centenario ( Site 0205) | Rosario | Santa Fe Province | 2002 | Argentina |
| Sanatorio Parque ( Site 0202) | Rosario | Santa Fe Province | S2000DVC | Argentina |
| Nepean Hospital ( Site 2700) | Kingswood | New South Wales | 2747 | Australia |
| Calvary Mater Newcastle ( Site 2703) | Waratah | New South Wales | 2298 | Australia |
| Frankston Hospital-Oncology and Haematology ( Site 2702) | Frankston | Victoria | 3199 | Australia |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) | Melbourne | Victoria | 3021 | Australia |
| Medizinische Universität Graz ( Site 0504) | Graz | Styria | 8036 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) | Linz | Upper Austria | 4020 | Austria |
| Kepler Universitätsklinikum ( Site 0507) | Linz | Upper Austria | 4021 | Austria |
| Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502) | Vienna | 1140 | Austria |
| Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501) | Vienna | 1210 | Austria |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106) | Kingston | Ontario | K7L 2V7 | Canada |
| Lakeridge Health ( Site 0102) | Oshawa | Ontario | L1G 2B9 | Canada |
| Anhui Cancer Hospital ( Site 2915) | Hefei | Anhui | 230031 | China |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901) | Beijing | Beijing Municipality | 100142 | China |
| Beijing Peking Union Medical College Hospital ( Site 2921) | Beijing | Beijing Municipality | 100730 | China |
| Fujian Provincial Cancer Hospital-oncology department ( Site 2904) | Fuzhou | Fujian | 350014 | China |
| Harbin Medical University Cancer Hospital-oncology of department ( Site 2920) | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital ( Site 2916) | Zhengzhou | Henan | 450008 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912) | Wuhan | Hubei | 430048 | China |
| Hubei Cancer Hospital ( Site 2922) | Wuhan | Hubei | 430079 | China |
| Hunan Cancer Hospital ( Site 2907) | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of Soochow University ( Site 2913) | Suzhou | Jiangsu | 215006 | China |
| Jilin Cancer Hospital-GCP office ( Site 2909) | Changchun | Jilin | 130000 | China |
| The First Hospital of Jilin University ( Site 2914) | Changchun | Jilin | 130021 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910) | Xi'an | Shaanxi | 710061 | China |
| Shanghai Chest Hospital-Oncology department ( Site 2900) | Shanghai | Shanghai Municipality | 200030 | China |
| Fudan University Shanghai Cancer Center ( Site 2908) | Shanghai | Shanghai Municipality | 200032 | China |
| Sichuan Cancer hospital. ( Site 2923) | Chengdu | Sichuan | 610042 | China |
| West China Hospital Sichuan University ( Site 2903) | Chengdu | Sichuan | 611135 | China |
| Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906) | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital-Oncology ( Site 2919) | Hangzhou | Zhejiang | 310022 | China |
| Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702) | Oulu | North Ostrobothnia | 90220 | Finland |
| Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700) | Vaasa | Pohjanmaa | 65130 | Finland |
| Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701) | Turku | Southwest Finland | 20520 | Finland |
| Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805) | Marseille | Bouches-du-Rhone | 13915 | France |
| CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800) | Toulouse | Haute-Garonne | 31400 | France |
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803) | Limoges | Haute-Vienne | 87042 | France |
| Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905) | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907) | Immenhausen | Hesse | 34376 | Germany |
| Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901) | Hanover | Lower Saxony | 30625 | Germany |
| LungenClinic Grosshansdorf-Onkologie ( Site 0903) | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900) | Gera | Thuringia | 07548 | Germany |
| Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002) | Athens | Attica | 115 26 | Greece |
| Sotiria Thoracic Diseases Hospital of Athens ( Site 1003) | Athens | Attica | 11527 | Greece |
| Metropolitan Hospital ( Site 1001) | Athens | Attica | 185 47 | Greece |
| University General Hospital of Heraklion ( Site 1004) | Heraklion | Irakleio | 71500 | Greece |
| European Interbalkan Medical Center ( Site 1000) | Thessaloniki | 570 01 | Greece |
| Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105) | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102) | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101) | Törökbálint | Pest County | 2045 | Hungary |
| Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104) | Kaposvár | Somogy County | 7400 | Hungary |
| St. James's Hospital ( Site 1200) | Dublin | D08 E9P6 | Ireland |
| Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201) | Dublin | Dublin 9 | Ireland |
| Rambam Health Care Campus-Oncology ( Site 1301) | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center-Oncology ( Site 1300) | Jerusalem | 9103102 | Israel |
| Sheba Medical Center-ONCOLOGY ( Site 1302) | Ramat Gan | 5265601 | Israel |
| Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402) | Naples | Campania | 80131 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401) | Milan | Lombardy | 20133 | Italy |
| Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403) | Rozzano | Milano | 20089 | Italy |
| Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400) | Rome | Roma | 00144 | Italy |
| Aichi Cancer Center ( Site 3016) | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East ( Site 3002) | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 3012) | Matsuyama | Ehime | 791-0280 | Japan |
| Kurume University Hospital ( Site 3014) | Kurume | Fukuoka | 830-0011 | Japan |
| National Hospital Organization Hokkaido Cancer Center ( Site 3015) | Sapporo | Hokkaido | 003-0804 | Japan |
| Kanazawa University Hospital ( Site 3006) | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kanagawa Cancer Center ( Site 3004) | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital ( Site 3001) | Sendai | Miyagi | 981-0914 | Japan |
| Niigata Cancer Center Hospital ( Site 3005) | Niigata | Niigata | 951-8566 | Japan |
| Kansai Medical University Hospital ( Site 3009) | Hirakata | Osaka | 573-1191 | Japan |
| Shizuoka Cancer Center ( Site 3007) | Nakatogari | Shizuoka | 411-8777 | Japan |
| Cancer Institute Hospital of JFCR ( Site 3003) | Koto | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 3013) | Fukuoka | 810-8563 | Japan |
| Okayama University Hospital ( Site 3011) | Okayama | 700-8558 | Japan |
| Klaipeda University Hospital-Oncology chemotherapy ( Site 1502) | Klaipėda | Klaipedos Miestas | 92288 | Lithuania |
| National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501) | Vilnius | Vilniaus Miestas | 08660 | Lithuania |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500) | Kaunas | LT-50161 | Lithuania |
| Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407) | Guadalajara | Jalisco | 44280 | Mexico |
| Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403) | Guadalajara | Jalisco | 44680 | Mexico |
| Arké SMO S.A. de C.V. ( Site 0401) | Mexico City | Mexico City | 06700 | Mexico |
| iCan Oncology Center Centro Medico AVE ( Site 0406) | Monterrey | Nuevo León | 64710 | Mexico |
| Centro de Investigacion Clinica de Oaxaca ( Site 0410) | Oaxaca City | 68020 | Mexico |
| Ziekenhuis Rijnstate ( Site 1606) | Arnhem | Gelderland | 6815 AD | Netherlands |
| Maastricht UMC+-Pulmonary disease ( Site 1602) | Maastricht | Limburg | 6229 HX | Netherlands |
| Jeroen Bosch Hospital-Pulmonology ( Site 1605) | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands |
| Isala, locatie Zwolle-Poli Longziekten ( Site 1612) | Zwolle | Overijssel | 8025 AB | Netherlands |
| Medische Centrum Leeuwarden ( Site 1619) | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| Erasmus Medisch Centrum ( Site 1621) | Rotterdam | South Holland | 3015 GD | Netherlands |
| Martini Ziekenhuis ( Site 1618) | Groningen | 9728 NT | Netherlands |
| Przychodnia Lekarska KOMED ( Site 1701) | Konin | Greater Poland Voivodeship | 62-500 | Poland |
| Med-Polonia Sp. z o. o. ( Site 1710) | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709) | Siedlce | Masovian Voivodeship | 08-110 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1700) | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703) | Przemyśl | Podkarpackie Voivodeship | 37-700 | Poland |
| Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706) | Prabuty | Pomeranian Voivodeship | 82-550 | Poland |
| Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707) | Bystra | Silesian Voivodeship | 43-360 | Poland |
| Champalimaud Foundation ( Site 1812) | Lisbon | Lisbon District | 1400-038 | Portugal |
| Hospital CUF Descobertas ( Site 1815) | Lisbon | Lisbon District | 1998-018 | Portugal |
| Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813) | Porto | 4099-001 | Portugal |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810) | Porto | 4200-072 | Portugal |
| MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905) | Bucharest | Bucharest | 022343 | Romania |
| Centrul medical Focus ( Site 1903) | Bucharest | Bucharest | 022548 | Romania |
| Cardiomed SRL Cluj-Napoca ( Site 1900) | Cluj-Napoca | Cluj | 400015 | Romania |
| Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904) | Craiova | Dolj | 200385 | Romania |
| Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901) | Craiova | Dolj | 200746 | Romania |
| Cabinet Medical Oncomed ( Site 1902) | Timișoara | Timiș County | 300239 | Romania |
| Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800) | Hwasun | Jeonranamdo | 58128 | South Korea |
| Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801) | Deagu | Taegu-Kwangyokshi | 41404 | South Korea |
| Chungnam national university hospital-Department of Internal Medicine ( Site 2802) | Daejeon | Taejon-Kwangyokshi | 35015 | South Korea |
| Korea University Guro Hospital-Internal Medicine ( Site 2803) | Seoul | South Korea |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102) | Madrid | Madrid, Comunidad de | 28041 | Spain |
| H.R.U Málaga - Hospital General-Oncology ( Site 2104) | Málaga | Malaga | 29011 | Spain |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100) | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103) | Seville | 41009 | Spain |
| Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402) | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407) | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe Universitesi-oncology hospital ( Site 2409) | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 2406) | Ankara | 06520 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital ( Site 2403) | Ankara | 06800 | Turkey (Türkiye) |
| Medipol University Medical Faculty-oncology ( Site 2400) | Istanbul | 34214 | Turkey (Türkiye) |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401) | Istanbul | 34722 | Turkey (Türkiye) |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 2408) | Izmir | 35575 | Turkey (Türkiye) |
| The Christie-Clinical Research Facility ( Site 2607) | Manchester | England | M20 4BX | United Kingdom |
| Mount Vernon Hospital ( Site 2602) | Northwood | Hillingdon | HA6 2RN | United Kingdom |
| Heartlands Hospital-Oncology Research ( Site 2604) | Birmingham | B9 5SS | United Kingdom |
| Plain Language Summary | View source |
| FG001 | Atezolizumab | Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab/Vibostolimab | Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve [AUC] 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
| BG001 | Atezolizumab | Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline | An ECOG Performance Status at baseline; ECOG= 0 (Fully active, able to carry on all pre-disease performance without restriction), or ECOG= 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for participant inclusion in the study and randomization was stratified by baseline ECOG score. | Count of Participants | Participants |
| |||||||||||||||
| Lactate Dehydrogenase (LDH) Status at Baseline | Randomization of participants in the study was stratified by LDH measurement at baseline (≤ or > upper limit of normal [ULN]). | Count of Participants | Participants |
| |||||||||||||||
| Presence of Liver Metastases at Baseline | Randomization of participants in the study was stratified by the presence of liver metastases at baseline (yes or no). | Count of Participants | Participants |
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| Presence of Brain Metastases at Baseline | Randomization of participants in the study was stratified by the presence of brain metastases at baseline (yes or no). | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data. | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
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| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented. | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
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| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen & Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or > upper limit of normal [ULN]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No). | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 25 months |
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| Secondary | Duration of Response (DOR) | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data. | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Not Posted | Up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an AE | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Not Posted | Up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to approximately 60 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. | Not Posted | Baseline and up to approximately 60 months | Participants |
Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab/Vibostolimab | Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve [AUC] 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. | 155 | 230 | 120 | 229 | 228 | 229 |
| EG001 | Atezolizumab | Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. | 141 | 230 | 96 | 229 | 222 | 229 |
| 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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| 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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| Myelosuppression | 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 |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dilated cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal 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 |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mesenteric artery thrombosis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal 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 |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bacterial 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 |
| |
| Catheter site infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| 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 |
| |
| Encephalitis cytomegalovirus | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | 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 |
| |
| Skin infection | 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 |
| |
| 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 |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | 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 |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypochloraemia | 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 |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal 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 |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aneurysm ruptured | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superior vena cava occlusion | 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 |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | 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 |
| |
| Abdominal pain upper | Gastrointestinal 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 |
| |
| Malaise | 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 |
| |
| 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 |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase 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 |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight 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 |
| |
| Hyperuricaemia | 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | 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 |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | 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 |
|
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 |
| May 13, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| 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 |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| C000594389 | atezolizumab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG= 1 |
|
| >Upper Limit of Normal (ULN) |
|
| No |
|
| No |
|
| OG001 | Atezolizumab | Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
|
|
|
| OG001 | Atezolizumab | Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
|
|
|
| Atezolizumab |
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. |
|
|