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Clinical Trials in China / NCT07330037
Recruiting Phase 2

TALENT Study: Phase II Trial of Adjuvant L-TIL Plus Tislelizumab in Resectable NSCLC Without pCR After Neoadjuvant Chemoimmunotherapy

NCT07330037 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Phase 2
Started
2025-12-01
Last updated
2026-01-09

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

L-TIL cells injectionTislelizumab →

L-TIL cells injection: Autologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion.

Tislelizumab: Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment.

Study summary

This study evaluates the preliminary efficacy and safety of adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC) who underwent surgery after neoadjuvant treatment with an immune checkpoint inhibitor plus platinum-based doublet chemotherapy but did not achieve a pathological complete response (pCR).

Eligibility

Sex
ALL
Min age
17 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC with imaging indicating resectable stage II-IIIB (N2) disease according to the ninth edition of the AJCC lung cancer TNM staging system; * No prior anti-tumor treatment; * Negative for EGFR/ALK/ROS1 mutations; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; * Undergone 2-4 cycles of neoadjuvant therapy combining immunotherapy and chemotherapy, followed by surgical resection with R0 margins but without achieving a complete pathological response (non-pCR); * Adequate organ function as defined below (without using any blood products or hematopoietic growth factors within 14 days): Normal bone marrow reserve: neutrophil count ≥1.5×10⁹/L, lymphocyte count ≥0.6×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90g/L; Normal renal function: serum creatinine ≤1.5 mg/dL and/or creatinine clearance rate ≥60 mL/min; Normal liver function: total bilirubin ≤1.5 times ULN, AST and ALT ≤1.5 times ULN; Normal coagulation function: APTT ≤1.5 times ULN, INR ≤1.5 times ULN, PT ≤1.5 times ULN; Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; Pulmonary function test showing FEV1 ≥60%; * For non-surgically sterilized or women of childbearing potential, must agree to use medically approved contraception (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of treatment; must have a negative serum or urine HCG test within 7 days prior to study entry; must not be breastfeeding; Exclusion Criteria: * Vaccination within 28 days prior to the first dose, except for inactivated vaccines; * Major surgery within 28 days prior to the first dose; * History of other malignancies within 5 years prior to screening; * Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (for inclusion criteria, ALT and AST levels must be within specified limits; for hepatitis B: HBV DNA \>10\^4/ml; for hepatitis C: HCV RNA \>10\^3/ml; for chronic hepatitis B carriers, HBV DNA \>2000 IU/ml (\>10\^4 copies/ml), antiviral treatment must be concurrently administered during the study period); * Unstable or severe concurrent diseases within 6 months prior to the first dose, such as severe/unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, pulmonary hypertension, life-threatening ventricular arrhythmias requiring maintenance therapy, stroke, and uncontrolled severe seizures; * Clinically significant active pneumonia or other respiratory system diseases severely affecting lung function at screening; * Active autoimmune diseases, history of autoimmune diseases, or conditions requiring systemic corticosteroids or immunosuppressive drugs; * Arterial or venous thrombotic events occurring within 6 months prior to screening; * History or CT findings indicating active tuberculosis within 1 year prior to enrollment that was untreated; * Active infections requiring systemic anti-infective treatment; * Active gastrointestinal bleeding or contraindications to IL-2 use; * Previous bone marrow transplant or solid organ transplant; * Other serious acute or chronic medical or psychiatric illnesses (including suicidal ideation or behavior within one year) that may increase the risk associated with participation in the study or administration of the investigational treatment, interfere with the investigational treatment and follow-up, or affect the subject's compliance;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07330037 on ClinicalTrials.gov ↗ ← All trials in China