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Protocol Summary


Protocol No.
PSCI-19-096
Prinicipal Investigator
Ma, Patrick
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
MK7339-013
Title
A Phase III Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib, Compared to Concurrent Chemoradiation Therapy Followed by Placebo in Participants with Newly Diagnosed Treatment-Naive Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK7339-013)
Objective
Primary Objectives
Objective: To compare progression free survival (PFS) per RECIST 1.1 as assessed by 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.

Objective: To compare overall survival (OS)
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.


Secondary Objectives
Objective: To evaluate the safety and tolerability of concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy alone.
Objective: To evaluate the safety and tolerability of concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab compared to concurrent chemoradiation therapy alone.

Objective: To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy alone with respect to objective response rate (ORR) as assessed by BICR per RECIST 1.1.
Objective: To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab to concurrent chemoradiation therapy alone with respect to ORR as assessed by BICR per RECIST 1.1

Objective: To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy alone with respect to duration of response (DOR) as assessed by BICR per RECIST 1.1.
Objective: To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab to concurrent chemoradiation therapy alone with respect to DOR as assessed by BICR per RECIST 1.1.

Objective: To evaluate the change from baseline (at cycle 1) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning following treatment with concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy alone.
Objective: To evaluate the change from baseline (at cycle 1) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning following treatment with concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab compared to concurrent chemoradiation therapy alone.

Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center