Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer: A Phase II, Single-Arm Clinical Study
Shanghai Pulmonary Hospital, Shanghai, China
54 participants
Jan 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
1. Neoadjuvant therapy phase: four planned doses of sintilimab 200 mg intravenous infusion at weeks -12, -9, -6, and -3 (Q3W); one planned dose of IBI310 1 mg/kg intravenous infusion at week -12; four planned doses of chemotherapy at weeks -12, -9, -6, and -3 (Q3W). Non-squamous NSCLC: pemetrexed 500 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. Squamous NSCLC: nanoparticle albumin-bound paclitaxel 260 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. 2. Surgery phase: At least 3 weeks after the last dose of the study drug , participants deemed operable by the investigator will undergo surgery.
Locations(1)
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NCT07410975