Clinical trial · Interventional
TILs Therapy for Multiple Primary Early-Stage NSCLC
Safety Study of Tumor-Infiltrating Lymphocytes (TILs) Therapy for Multifocal Early-Stage Non-Small Cell Lung Cancer (NSCLC)
NCT07498439CI-TRIAL-00106678not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Early-stage Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TILs injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A single-arm TILs treatment
- description
- 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
- interventionNames
- Drug: TILs injection
Primary outcomes (1)
- measure
- 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)
- timeFrame
- up to three years
- description
- Incidence of treatment-related adverse events(AEs)Description: Number and severity of adverse events graded according to CTCAE v5.0.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.