Lung Cancer Clinical Trial
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Summary
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of advanced NSCLC
Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
Have measurable disease based on RECIST 1.1
Have a life expectancy of at least 3 months
Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
PD-L1 high status as determined by central testing
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
Other protocol defined exclusion criteria could apply
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There are 115 Locations for this study
Huntsville Alabama, 35805, United States
Los Angeles California, 90048, United States
Orange California, 92868, United States
San Diego California, 92120, United States
Santa Barbara California, 93105, United States
Colorado Springs Colorado, 80907, United States
Norwich Connecticut, 06360, United States
Jacksonville Florida, 32256, United States
Pensacola Florida, 32503, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40202, United States
Detroit Michigan, 48202, United States
Kansas City Missouri, 64132, United States
Lincoln Nebraska, 68510, United States
Paramus New Jersey, 07652, United States
Rochester New York, 14642, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Bedford Texas, 76022, United States
Sugar Land Texas, 77479, United States
Fairfax Virginia, 22031, United States
Berazategui , B1880, Argentina
Ciudad Autonoma Buenos Aires , C1426, Argentina
Cordoba , X5000, Argentina
Rio Cuarto , 5800, Argentina
Rosario , S2000, Argentina
San Miguel de Tucuman , 4000, Argentina
Bruxelles , 1090, Belgium
Hasselt , 3500, Belgium
Pellenberg , 3212, Belgium
Yvoir , 5530, Belgium
Barretos , 14784, Brazil
Fortaleza , 60336, Brazil
Porto Alegre , 90610, Brazil
Rio de Janeiro , 20230, Brazil
Salvador , 40170, Brazil
Santo Andre , 09060, Brazil
St. John New Brunswick, E2L 4, Canada
Alberta , T2N 4, Canada
Ontario , L3Y 2, Canada
Beijing , 10014, China
Guangzhou , 51008, China
Shanghai , 20003, China
Pessac Gironde, 33604, France
Creteil Cedex Val De Marne, 94010, France
Bouches-du-Rhône , 13915, France
Lyon Cedex 08 , 69373, France
Rennes cedex 09 , 35033, France
Saint Herblain , 44805, France
Toulouse , 31059, France
Berlin , 10967, Germany
Gauting , 82131, Germany
Grosshansdorf , 22927, Germany
Hannover , 30625, Germany
Luebeck , 23538, Germany
Regensburg , , Germany
Athens , 11525, Greece
Athens , 11527, Greece
Heraklion , 71110, Greece
Thessaloniki , 56429, Greece
Hong Kong , 00000, Hong Kong
Hong Kong , , Hong Kong
Shatin , 00000, Hong Kong
Avellino , 83100, Italy
Aviano , 33081, Italy
Bologna , 40138, Italy
Catania , 95123, Italy
Catanzaro , 88100, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Sapporo-shi Hokkaido, 003-0, Japan
Chuo-ku , 104-0, Japan
Hidaka-shi , , Japan
Kitaadachigun , 362-0, Japan
Koto-ku , 135-8, Japan
Kurume-shi , 830-0, Japan
Osaka-shi , 541-8, Japan
Osakasayama-sh , 589-8, Japan
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Maastricht , 6202 , Netherlands
Rotterdam , 3015 , Netherlands
Tilburg , 5022 , Netherlands
Barcelona , 08003, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
L'Hospitalet de Llobregat , 08908, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Taichung , 40705, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taipei , 11490, Taiwan
Adana , 01370, Turkey
Ankara , 06105, Turkey
Edirne , 22030, Turkey
Kocaeli , 41380, Turkey
Dnipro , 49102, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kharkiv , 61070, Ukraine
Lutsk , 43018, Ukraine
Uzhgorod , 88000, Ukraine
Zaporizhzhia , 69059, Ukraine
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