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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 (Jun 2026). This Phase 2 trial studies Tislelizumab for stage iii nsclc.

Phase 2RecruitingFondazione Ricerca TraslazionaleNCT07264647Data as of Jun 2026Location: Italy

Treatment: TislelizumabA 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).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Tislelizumab

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)

Demographics

Ages ≤ 99

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT07264647 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CD274?

Yes, CD274 TPS ≥ 1% is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR wild-type is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage III is required.

Is there an age limit?

Yes. Patients must be 99 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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