Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

Official Title

A Phase 3, Multicentre, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)

Summary:

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

Trial Description

Primary Outcome:

  • Overall Survival (OS)
  • Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
Secondary Outcome:
  • Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel
  • Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy
  • Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Number of Participants Experiencing an Adverse Event (AE)
  • Number of Participants Discontinuing Study Treatment Due to an AE
  • Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
  • Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score
  • Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
  • Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
  • Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
  • Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
  • Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score
  • Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
  • Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
  • Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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