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Phase II Study of Sintilimab and Anti-CTLA-4 Antibody with Chemotherapy as Pre-Surgery Treatment for Resectable Stage II-III Non-Small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-02-13
54
Participants Needed
1
Research Sites
82 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the major pathologic response MPR rate of a neoadjuvant treatment combining sintilimab a PD-1 inhibitor, IBI310 an anti-CTLA-4 antibody, and chemotherapy in patients with PD-L1-negative stage II to IIIB non-small cell lung cancer NSCLC who are scheduled for surgery. The study focuses on patients without distant metastasis or unresectable tumor extension, assessing the effectiveness of this treatment strategy before surgery. Participants will receive a neoadjuvant therapy consisting of four planned doses of sintilimab 200 mg intravenous infusion every 3 weeks at weeks -12, -9, -6, and -3, and one dose of IBI310 1 mgkg intravenous infusion at week -12. Chemotherapy is also given at the same weeks, with regimens differing based on cancer type non-squamous NSCLC patients receive pemetrexed plus carboplatin, while squamous NSCLC patients receive nanoparticle albumin-bound paclitaxel plus carboplatin. Surgery will occur at least 3 weeks after the last dose if the patient is deemed operable. After surgery, patients may continue standard adjuvant therapy with PD-1 inhibitors for up to one year. During the study, participants will be monitored for responses to treatment, including the major pathologic response rate approximately 5 months after enrollment. Safety and tolerability will be assessed by tracking treatment-emergent adverse events from consent through 30 days after the last drug administration. Additional outcomes include pathological complete response, overall response rate at 12 weeks, event-free survival, and overall survival for up to 5 years. The total study duration includes the neoadjuvant phase, surgery, possible adjuvant therapy, and long-term follow-up.
CONDITIONS
Brief Title
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
Research Team
C
Chang Chen, MD
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