At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed stage IV (M1a or M1b) squamous NSCLC
- ✓Measurable disease by RECIST 1.1
- ✓No prior systemic treatment for metastatic NSCLC
- ✓Tumor tissue available from non-irradiated sites for testing
- ✕Non-squamous NSCLC histology
- ✕Prior systemic cytotoxic chemotherapy for metastatic disease
- ✕Prior targeted or biological antineoplastic therapy for metastatic disease (e.g., erlotinib, crizotinib, cetuximab)
- ✕Prior anti-PD-1, PD-L1, or PD-L2 therapy or other immuno-regulatory agent targeting
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Paclitaxel, and 2 other interventions for Non-small Cell Lung Cancer. Completed, enrolled 125 participants across 1 site.
Detailed Summary
In this China extension study, carboplatin and paclitaxel with or without pembrolizumab (MK-3475, KEYTRUDA®) will be administered to Chinese adults with first line metastatic squamous non-small cell lung cancer (NSCLC). The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival (OS) in Chinese participants. After analysis of interim results was conducted, the protocol was amended (Amendment 5) to allow participants the option to discontinue placebo in the control arm and to switch to pembrolizumab in the event of documented progressive disease as assessed by central review.
Study Details
Timeline
Interventions
IV infusion
IV infusion
IV infusion Carboplatin dose should not exceed 900 mg.
IV infusion