TILs Therapy for Multiple Primary Early-Stage NSCLC

Starting soon · Early Phase 1

Conditions studied: Primary Early-stage Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT07498439

Run by

Tianjin Medical University General Hospital

People needed

50

Starts

2026-03-31

Expected to finish

2030-03-31

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Creatinine ≤ 1.5 × ULN; Oxygen saturation > 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
• Estimated survival > 5 years with complete clinical documentation.

You may not qualify if…

• 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);
• HIV infection or syphilis infection;
• Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;
• Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Full record on ClinicalTrials.gov

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