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)

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).

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Biological: L-TIL cells injection; Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dongsheng Yue, MD. Ph.D; Phone Number: +86-22-23340123-6417; Email: yuedongsheng_cg@163.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Liang Liu, MD. Ph.D; Phone Number: +86-22-23340123-6417; Email: liuliang@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: L-TIL Cells Plus Tislelizumab; Participants will receive adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab. 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 will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year Disease Free Survival	2-year DFS is defined as the proportion of patients who remain free of disease recurrence, second primary malignancy, or death from any cause at 24 months after surgery.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival (DFS)	DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first.	Up to 3 years
Overall survival (OS)	OS defined as the time from the date of randomization to the date of death due to any cause, in Stage II-IIIB and in Stage IB-IIIB	Up to 5 years
Adverse event (AE)	Incidence and severity of AEs, with severity as determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)	Up to 5 years
Locoregional Recurrence-Free Survival (LRFS)	LRFS was calculated from the date of surgery to the date of first locoregional recurrence; patients without such an event were censored at the date of last follow-up or death.	Up to 3 years
Distant Metastasis-Free Survival (DMFS)	DMFS was measured from the date of surgery to the date of first distant metastasis; patients without distant metastasis were censored at the last follow-up or at death, whichever occurred first.	Up to 3 years
Lung Cancer-Specific Survival (LCSS)	Lung cancer-specific survival (LCSS) was calculated from the date of surgery to the date of death due to lung cancer; deaths from other causes were censored at the time of death.	Up to 5 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tislelizumab
• Other Study ID Numbers: TALENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No