OncoMatch/Clinical Trials/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
Is NCT07410975 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies sintilimab+IBI310+chemotherapy for nsclc stage ii.
Treatment: sintilimab+IBI310+chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
no EGFR mutation
Required: ALK wild-type
no ALK rearrangement
Required: PD-L1 (CD274) expression negative (22C3 or E1L3N) (negative)
PD-L1 expression negative (22C3 or E1L3N)
Disease stage
Required: Stage II, IIIA, IIIB (AJCC 9th)
Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy
Cannot have received: immunotherapy
No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy
Cannot have received: radiotherapy
No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy
Lab requirements
Blood counts
haemoglobin ≥ 90 g/l (no transfusion within 28 days); absolute neutrophil count ≥ 1.5 × 10⁹/l; platelet count ≥ 100 × 10⁹/l (no platelet transfusion or il-11 within 14 days)
Kidney function
creatinine clearance ≥ 60 ml/min (cockcroft-gault)
Liver function
total bilirubin ≤ 1.5 × uln (≤ 2.5 × uln in gilbert's syndrome or hepatic metastases); alt and ast ≤ 3 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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