At a glance
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A Multinational, Multicenter, Phase III, Randomized Open-label Trial of Pembrolizumab Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab and Docetaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 425 participants.
Detailed Summary
The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) positive tumors who have experienced disease progression after platinum-containing systemic therapy. The primary hypotheses of this study are that pembrolizumab (MK-3475) prolongs overall survival (OS) and that pembrolizumab prolongs progression-free survival (PFS), compared to docetaxel in participants with PD-L1 positive tumors.
Study Details
Timeline
Interventions
Pembrolizumab administered IV at 2 mg/kg on Day 1 of each 21-day cycle for up to 35 doses (approximately 24 months).
Docetaxel administered IV at 75 mg/m\^2 on Day 1 of each 21-day cycle as per the approved product label.