Adjuvant L-TIL plus tislelizumab after surgery for resectable NSCLC without pCR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, single-center trial of adjuvant cellular therapy (L-TIL) combined with tislelizumab in patients with resectable stage II–IIIB non-small cell lung cancer who had neoadjuvant chemoimmunotherapy followed by R0 resection but did not achieve a pathological complete response. Eligible patients must be EGFR/ALK/ROS1-negative with ECOG 0–1 and adequate organ function. Participants will receive injections of expanded L-TIL cells alongside scheduled doses of tislelizumab and will be followed for safety and preliminary anti-tumor activity. The trial aims to determine whether this combination can reduce recurrence risk and is tolerable in the post-surgery adjuvant setting.

Why it matters

Who can join: the full rules

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;

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Platinum-doublet chemotherapy followed by large-fraction radiotherapy with tislelizumab for advanced non-squamous NSCLC

  We will try platinum-based doublet chemotherapy followed by large-fraction radiotherapy together with tislelizumab in people with stage IIIB/C–IV non-squamous non-small cell lung cancer who cannot tolerate concurrent chemoradiotherapy.

  Recruiting Phase 2 Zibo Municipal Hospital · Zibo, Shandong · NCT07198217

• Tislelizumab with Anlotinib and Nab-Paclitaxel before surgery for resectable NSCLC

  A group of adults with stage II–III non-small cell lung cancer is given tislelizumab plus anlotinib and nab-paclitaxel before surgery to see if the treatment helps shrink tumors and is safe.

  Recruiting Phase 2 Qilu Hospital of Shandong University · Jinan, Shandong · NCT07089199

• Tislelizumab with platinum-doublet chemotherapy followed by hypofractionated radiotherapy for stage IIIB/C–IV non-squamous NSCLC

  This trial tests whether adding Tislelizumab to platinum-doublet chemotherapy followed by hypofractionated radiotherapy can help people with stage IIIB/C–IV non‑squamous non‑small cell lung cancer who have not had prior systemic therapy.

  Recruiting Phase 2 Zibo Municipal Hospital · Zibo, Shandong · NCT07085182

• Using MRD-guided treatment with tislelizumab and chemotherapy for resected NSCLC

  This study is testing if a personalized treatment plan using a new drug and chemotherapy can help patients with early-stage non-small cell lung cancer do better after surgery compared to standard treatment.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT05286957

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.