Spots Global Cancer Trial Database for Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) [MK-7902-007/E7080-G000-314/LEAP-007] - China Extension Study
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Trial Identification
Brief Title: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) [MK-7902-007/E7080-G000-314/LEAP-007] - China Extension Study
Official Title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Study ID: NCT04676412
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Detailed Description: The main study will have a duration of approximately 5 years and the extension period will have a duration of approximately 1 year. The base study and the China extension to MK-7902-007 (NCT03829332) will enroll a total of approximately 120 Chinese participants. As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain on treatment will receive open-label pembrolizumab only.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital ( Site 0108), Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0113), Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0105), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 0102), Beijing, Beijing, China
Beijing Chest Hospital Capital Medical University ( Site 0111), Beijing, Beijing, China
Xiangya Hospital of Central South University ( Site 0115), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0104), Changsha, Hunan, China
Zhongshan Hospital Fudan University ( Site 0100), Shanghai, Hunan, China
Jiangsu Cancer Hospital ( Site 0101), Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0110), Chang chun, Jilin, China
Shanghai Chest Hospital ( Site 0112), Shanghai, Shanghai, China
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103), XiAn, Shanxi, China
West China Hospital of Sichuan University ( Site 0117), Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University ( Site 0106), Hangzhou, Zhejiang, China
Hangzhou First People's Hospital ( Site 0109), Hangzhou, Zhejiang, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0116), Hangzhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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