Science and Research

A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemebtrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) +/- Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants with Metastatic Nonsquamous Non

The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.

The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.

Study details
Study-ID: NCT03829319, 2018-003824-35
Study-ID: NCT03829319, 2018-003824-35
DZL Disease Area: LC
DZL Disease Area: LC
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL on steering board
DZL Role: DZL on steering board
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: ARCN
DZL Participating Sites: ARCN
Start Date: 25.03.2019
Completion Date: 30.08.2024
Status: Closed
Status: Closed
DZL on steering board
Link to Study


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