NCT07122687

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.

Conditions

• Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	500 mg/m2 D1 IV Q3W
DRUG	Cisplatin	75 mg/m2 D1 IV Q3W
DRUG	IBI363	1.5 mg/kg D1 IV Q3W
DRUG	Carboplatin	AUC 5 mg/ml/min D1 IV Q3W
DRUG	Keytruda	200mg D1 IV Q3W

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-11-30
• Completion: 2030-04-30
• First posted: 2025-08-14
• Last updated: 2025-09-30

Locations

1 site across 1 country: China