NCT07217301

IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed

A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Fortvita Biologics (USA)Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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/m² every 3 weeks (Q3W), starting from C1D1 21-day cycle duration Dose Reduction: as per label

Conditions

• iO Resistant sqNSCLC

Interventions

Type	Name	Description
DRUG	IBI363	Investigational product will be administered by IV infusion
DRUG	Control Arm	Comparator product will be administered by IV infusion

Timeline

• Start date: 2025-11-26
• Primary completion: 2028-11-01
• Completion: 2029-12-01
• First posted: 2025-10-15
• Last updated: 2026-03-09

Locations

42 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study