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 Non-small Cell Lung Cancer (NSCLC)(MK-7902-007/E7080-G000-314/LEAP-007)

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 Non-small Cell Lung Cancer (NSCLC) Whose Tumours Have a Tumour Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

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 tumours have a programmed cell death-ligand 1 (PD-L1) Tumour 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 Tumours 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).

Trial Description

Primary Outcome:

• Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
• Overall Survival (OS)

• Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
• Number of Participants Who Experience an Adverse Event (AE)
• Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
• Change from Baseline in Global Health Status (GHS)(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score
• Change from Baseline in Quality of Life (QoL)(EORTC QLQ-C30 Item 30) Score
• Change from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
• Change from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
• Change from Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
• Change from Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
• Time to True Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)(EORTC QLQ-C30 Item 29) Score
• Time to True Deterioration (TTD) Based on Change from Baseline in Quality of Life (QoL)(EORTC QLQ-C30 Item 30) Score
• Time to True Deterioration (TTD) Based on Change from Baseline in the Composite Endpoint of Cough & Chest Pain (EORTC QLQ-LC13 Items 31 & 40) or Dyspnea (EORTC QLQ-C30 Item 8)
• Time to True Deterioration (TTD) Based on Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score

View this trial on ClinicalTrials.gov