Primary Early-stage Non-small Cell Lung Cancer
Conditions
Keywords
TILs, NSCLC
Brief summary
This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC
Detailed description
This study is an open-label, single-arm, prospective clinical trial. 50 subjects with multiple primary early-stage non-small cell lung cancer (NSCLC), including those with malignant pleural effusion, will be enrolled and administered with tumor-infiltrating lymphocytes (TILs) injection therapy. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up, so as to systematically evaluate the safety and effectiveness of TILs treatment for multiple
Interventions
DRUGTILs injection
Experimental: Surgically collect fresh tumor tissue or malignant pleural effusion to isolate immune cells, and prepare TILs Infusion. Trial product: TILs Injection. Administration route: Intravenous Infusion
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years, male or female; 2. Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation; 3. Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments; 4. Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes; 5. ECOG performance status score of 0-2; 6. HGB ≥70 g/L, transfusion-eligible; 7. No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria: Creatinine ≤ 1.5 × ULN; Oxygen saturation \> 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Estimated survival \> 5 years with complete clinical documentation.
Exclusion criteria
1. Patients with pathological diagnosis of small cell lung cancer components; 2. Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment; 3. Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance; 4. Patients currently undergoing steroid therapy; 5. Concurrent severe or persistent infections unresponsive to effective control; 6. Concurrent severe autoimmune disease or congenital immunodeficiency; 7. History of severe allergic reactions to biological products (including antibiotics); 8. Active hepatitis (quantitative hepatitis B virus DNA \[HBV-DNA\] above the lower limit of detection for the assay method, or positive hepatitis C antibodies \[HCV-Ab\] with HCV-RNA above the assay method's lower limit of detection); 9. HIV infection or syphilis infection; 10. Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months; 11. Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| According to the incidence of treatment-related adverse events（AEs）to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) therapy for multiple primary early-stage Non-Small Cell Lung Cancer （NSCLC） | up to three years | Incidence of treatment-related adverse events（AEs）Description: Number and severity of adverse events graded according to CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| According to the subgroup analysis of TILs in patients with multiple primary early-stage NSCLC to analyze the correlation between TILs and disease prognosis | up to three months | TILs subgroup analysis Description: Composition, phenotype, and function of TILs |
Outcome results
None listed