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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-TIL Cells Plus Tislelizumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-TIL cells injection | Biological | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
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%;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongsheng Yue, MD. Ph.D | Contact | +86-22-23340123-6417 | yuedongsheng_cg@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Tislelizumab | Drug | Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment. |
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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 |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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