NCT03829319

Safety and Efficacy Study 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 (MK-7902-006/E7080-G000-315/LEAP-006)

A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 761 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nonsquamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion Q3W
DRUG	Carboplatin	IV infusion Q3W
DRUG	Cisplatin	IV infusion Q3W
DRUG	Pemetrexed	IV infusion Q3W
DRUG	Lenvatinib	Oral capsule once daily
DRUG	Placebo matching lenvatinib	Oral capsule once daily

Timeline

• Start date: 2019-03-25
• Primary completion: 2023-08-11
• Completion: 2024-08-30
• First posted: 2019-02-04
• Last updated: 2026-02-05
• Results posted: 2025-02-21

Locations

158 sites across 17 countries: United States, Argentina, Australia, Canada, Chile, China, France, Germany, Israel, Japan, New Zealand, Poland, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study