Clinical Trial Protocol Summary

Protocol Number: ONCO-2024-042
Phase: III Randomized, Double-Blind
Indication: Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Design:
- Multicenter, randomized 2:1 (treatment vs placebo)
- Stratification factors: ECOG performance status (0 vs 1), PD-L1 expression (≥50% vs <50%), prior lines of therapy (1 vs 2)
- Primary endpoint: Overall Survival (OS) with planned interim analysis at 60% events
- Key secondary endpoints: Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR)
- Safety monitoring: Independent Data Safety Monitoring Board reviews every 6 months

Dosing:
- Investigational product: 200mg IV every 3 weeks
- Treatment duration: until progressive disease, unacceptable toxicity, or maximum 24 months
- Dose modifications: reduce to 150mg for Grade 3 adverse events, discontinue for Grade 4

Enrollment:
- Target: 450 patients across 80 sites in North America, Europe, and Asia-Pacific
- Key inclusion: age ≥18, confirmed NSCLC, measurable disease per RECIST v1.1, adequate organ function
- Key exclusion: active brain metastases, autoimmune disease requiring systemic treatment, prior anti-PD-1/PD-L1 therapy
- Enrollment period: 18 months from first patient in
