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RECRUITING
NCT07330037
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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).

Official title: A Prospective Phase II Clinical Trial Evaluating Liquid Tumor-infiltrating Lymphocytes (L-TIL) in Combination With Tislelizumab as Adjuvant Therapy in Patients With Resectable Stage II to IIIB (N2) Non-small Cell Lung Cancer (NSCLC) Who Have Undergone Surgery Following Neoadjuvant Treatment With an Immune Checkpoint Inhibitor Plus Platinum-based Doublet Chemotherapy and Did Not Achieve a Pathological Complete Response (pCR)

Key Details

Gender

All

Age Range

17 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2025-12-01

Completion Date

2028-12-31

Last Updated

2026-01-09

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

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.

DRUG

Tislelizumab

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

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China