10334MK7339-013OpenA 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)
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 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.NCT04624204IndustryAdultTreatmentBiological: Pembrolizumab 200 mg
Biological: Pembrolizumab 400 mg
Drug: Pembrolizumab placebo (saline)
Drug: Olaparib 300 mg BID
Drug: Olaparib matching placebo
Drug: Etoposide 100 mg/m^2
Drug: Platinum, investigator's choice
Radiation: Standard Thoracic Radiotherapy
Radiation: Prophylactic Cranial Irradiation (PCI)IIILungThis study investigates the following condition or disease: Small Cell Lung Cancer Chen, KevinMedstar Franklin Square Medical CenterThoracic/CNS/H&N/ThyroidOncology GroupMHRI Oncology Baltimore2021R3.1 Build 22 <a href="https://advarra.com" target="_blank">© 2024 Advarra, Inc.</a>