Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Summary:

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).

Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.

Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

Trial Description

Primary Outcome:

• Progression-free Survival Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
• Overall Survival: the time from randomization to death due to any cause

• Number of Participants Experiencing an Adverse Events (AEs)
• Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)
• Objective Response (OR): Complete Response (CR) or Partial Response (PR)
• Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first
• Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
• Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
• Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
• Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
• Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
• Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
• Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score
• Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) 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 Score
• Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
• Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
• Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
• Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels

View this trial on ClinicalTrials.gov