A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
This study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC
Primary Objectives: To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to progression-free survival (PFS) assessed according to RECIST 1.1 (Section 18.104.22.168) by blinded independent central review (BICR). To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to overall survival (OS). Secondary Objectives: To evaluate the safety and tolerability of pembrolizumab plus maintenance olaparib compared to pembrolizumab plus placebo. 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 plus maintenance olaparib compared to pembrolizumab plus placebo.
Chemotherapy (NOS); Immunotherapy; Therapy (NOS)
Nab-paclitaxel (Abraxane); Olaparib (Lynparza); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Placebo (); Taxol (paclitaxel); carboplatin (); paclitaxel ()
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