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)

Nonsquamous Non-small Cell Lung Cancer Clinical Trial

Official title:
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 Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Nonsquamous Non-small Cell Lung Cancer

Clinical Trial Details

NCT number	NCT03829319
Study type	Interventional
Source	Merck Sharp & Dohme LLC
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	March 25, 2019
Completion date	June 21, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04750083` - HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer	Phase 2/Phase 3
Active, not recruiting	`NCT04716933` - 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)-China Extension Study	Phase 3
Recruiting	`NCT03863483` - A Study of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.	Phase 2
Recruiting	`NCT03830411` - A Study of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy	Phase 2
Active, not recruiting	`NCT05338970` - HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy	Phase 3
Recruiting	`NCT06173505` - Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC	Phase 1/Phase 2