IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed
Status:
NOT_YET_RECRUITING
Trial end date:
2029-12-01
Target enrollment:
Participant gender:
Summary
Phase: 3 Type: Randomized, open-label, multi-regional, multi-center Population: Adults with advanced/metastatic squamous Non Small Cell Lung Cancer (NSCLC), post-progression on platinum chemo + PD-1/PD-L1 immunotherapy Enrollment: \~600 participants Randomization: 1:1 (IBI363 vs. docetaxel)
Stratification factors:
1. Primary vs. acquired IO resistance
2. Concurrent vs. sequential prior chemo-immunotherapy
3. Region (Asia vs. non-Asia)
Treatment Arms:
1. IBI363 Arm (Investigational Drug):
Priming dose: 0.1 mg/kg on Day 1 of Cycle 1 (C1D1) Intended dose: 3 mg/kg every 3 weeks (Q3W) starting Day 8 of Cycle 1 (C1D8) Cycle duration: 28 days for Cycle 1, then 21 days from Cycle 2 onward Dose adjustments: Up to 2 reductions (1.5 mg/kg or 1 mg/kg Q3W) allowed for adverse events (AEs) Re-priming protocol: Required if delays in dosing exceed defined thresholds (e.g., \>10 days post-priming or 5 weeks since last dose)
2. Control Arm (Docetaxel):
75 mg/m every 3 weeks (Q3W), starting from C1D1 21-day cycle duration Dose Reduction: as per label