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A Phase 3 Study of Pembrolizumab (MK-7339) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib Compared with Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
Primary:
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo with concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olapariv to concurrent chemoradiation therapy followed by durvalumab with respect to overall survival.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo to concurrent chemoradiation therapy followed by durvalumab with respect to overall survival.
Secondary:
To evaluate the safety and tolerability of pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy followed by durvalumab.
To evaluate the safety and tolerability of pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo compared to concurrent chemoradiation therapy followed by durvalumab.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to objective response rate and duration of response per RECIST 1.1 as assessed by blinded independent central review.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo to concurrent chemoradiation therapy followed by durvalumab with respect to objective response rate and duration of response per RECIST 1.1 as assessed by blinded independent central review.
To evaluate the change from baseline (at randomization) and the time to true deterioration in global health status/QoL, cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy followed by durvalumab.
To evaluate the change from baseline (at randomization) 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 pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo compared to concurrent chemoradiation therapy followed by durvalumab.
Primary:
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo with concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olapariv to concurrent chemoradiation therapy followed by durvalumab with respect to overall survival.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo to concurrent chemoradiation therapy followed by durvalumab with respect to overall survival.
Secondary:
To evaluate the safety and tolerability of pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy followed by durvalumab.
To evaluate the safety and tolerability of pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo compared to concurrent chemoradiation therapy followed by durvalumab.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to objective response rate and duration of response per RECIST 1.1 as assessed by blinded independent central review.
To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo to concurrent chemoradiation therapy followed by durvalumab with respect to objective response rate and duration of response per RECIST 1.1 as assessed by blinded independent central review.
To evaluate the change from baseline (at randomization) and the time to true deterioration in global health status/QoL, cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy followed by durvalumab.
To evaluate the change from baseline (at randomization) 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 pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus placebo compared to concurrent chemoradiation therapy followed by durvalumab.
Recruitment Status
Past Studies