NCT07408635

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy to Convert Initially Unresectable Stage III Non-Small Cell Lung Cancer To Resectable Disease: a Phase II, Single-Arm Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.

Detailed description

NSCLC patients receive IBI363 combined with platinum-based chemotherapy. If multidisciplinary team (MDT) assessment determines the patient is surgically eligible, surgery is performed followed by 1 year of standard adjuvant therapy. If, after 4 treatment cycles, MDT assessment determines the tumor remains unresectable, concurrent chemoradiotherapy followed by immune checkpoint inhibitor consolidation therapy is administered. This study aims to evaluate the efficacy of IBI363 combined with chemotherapy for neoadjuvant treatment of initially unresectable NSCLC based on R0 resection rate, major pathological response (MPR) rate, and pathological complete response (pCR) rate.

Conditions

• Unresectable Stage III Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	IBI363 + Chemotherapy	1. Neoadjuvant treatment: IBI363 combined with platinum-based chemotherapy. 2. Multidisciplinary team(MDT) assessment: Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.

Timeline

• Start date: 2026-01-07
• Primary completion: 2028-06-06
• Completion: 2030-01-06
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: China