NCT07330037

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China