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)

Conditions

• Nonsquamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  IV infusion Q3W
• Carboplatin — DRUG
  IV infusion Q3W
• Cisplatin — DRUG
  IV infusion Q3W
• Pemetrexed — DRUG
  IV infusion Q3W
• Lenvatinib — DRUG
  Oral capsule once daily
• Placebo matching lenvatinib — DRUG
  Oral capsule once daily

Study Details

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.

Key Dates

Start date

Mar 25, 2019

Status verified

Dec 2025

Primary completion

Aug 11, 2023

Completion

Aug 30, 2024

Study Design

Enrollment

761 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
  Participants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
• Placebo Comparator: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
  In Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.

Primary Outcome Measure

Part 1: Number of Participants With a Dose-limiting Toxicity (DLT) [ Time Frame: Cycle 1; each cycle is 21 days (up to 21 days) ]

Locations (17)

Related coverage on Hipa.ai

• Pembrolizumab + Lenvatinib Fails to Significantly Improve PFS in NSCLC
  Pembrolizumab · Feb 21, 2025 · ClinicalTrials.gov

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