drugset
drugset / Trial / NCT07410975

Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer

NCT07410975 ↗

Phase 2 Recruiting 54 enrolled Shanghai Pulmonary Hospital, Shanghai, China
NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.

Timeline

Start
2026-01-10
Primary completion
2028-06-10
Completion
2030-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI310 Monoclonal antibody 1 mg/kg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule 260 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma