Not Yet RecruitingEarly Phase 1

TILs Therapy for Multiple Primary Early-Stage NSCLC

50 participantsStarted 2026-03-31

Plain-language summary

This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years, male or female;
✓. 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;
✓. 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;
✓. Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;
✓. ECOG performance status score of 0-2;
✓. HGB ≥70 g/L, transfusion-eligible;
✓. No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria:
✓. Estimated survival \> 5 years with complete clinical documentation.

Exclusion criteria

✕. Patients with pathological diagnosis of small cell lung cancer components;
✕. Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
✕. Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;
✕. Patients currently undergoing steroid therapy;
✕. Concurrent severe or persistent infections unresponsive to effective control;
✕. Concurrent severe autoimmune disease or congenital immunodeficiency;
✕. History of severe allergic reactions to biological products (including antibiotics);
✕. 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);

What they're measuring

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

Trial details

NCT IDNCT07498439

SponsorTianjin Medical University General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

View on ClinicalTrials.gov More Primary Early-stage Non-small Cell Lung Cancer trials