OncoMatch/Clinical Trials/NCT07264647
Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
Is NCT07264647 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab for stage iii nsclc.
Treatment: Tislelizumab — A Ph.2, single-arm, monocentric, trial of neo-adjiuvant chemo-immunotherapy for stage III, PD-L1 positive, NSCLC. Adults and smokers (past or current) diagnosed with stage III NSCLC without driver molecular alterations (EGFR, ALK, ROS1, RET).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) TPS ≥ 1% (≥ 1%)
PD-L1 TPS ≥ 1% according to local testing
Required: EGFR wild-type
No evidence of EGFR mutations by local testing
Required: ALK wild-type
No evidence of ALK rearrangements by local testing
Required: ROS1 wild-type
No evidence of ROS1 rearrangements by local testing
Required: RET wild-type
No evidence of RET rearrangements by local testing
Disease stage
Required: Stage III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any therapy for current lung cancer
Any previous therapy for current lung cancer, including chemotherapy or radiation therapy
Cannot have received: immune checkpoint inhibitor
Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9 /L. Platelets ≥ 75 x 10^9 /L. Hemoglobin ≥ 90 g/L. Must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening.
Kidney function
Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2. For patients intended to receive cisplatin: creatinine clearance 60mL/min. For patients intended to receive carboplatin: creatinine clearance 45mL/min.
Liver function
Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome). AST and ALT ≤ 2.5 x ULN.
Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug: Patients must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following: Absolute neutrophil count ≥ 1.5 x 109 /L Platelets ≥ 75 x 109 /L Hemoglobin ≥ 90 g/L Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation. For patients intended to receive cisplatin: creatinine clearance 60mL/min For patients intended to receive carboplatin: creatinine clearance 45mL/min Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome). AST and ALT ≤ 2.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time 1.5ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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