TILs Therapy for Multiple Primary Early-Stage NSCLC

Prior treatment

• Patients currently undergoing steroid therapy;
• Concurrent severe or persistent infections unresponsive to effective control;
• Concurrent severe autoimmune disease or congenital immunodeficiency;

Other illness

• Patients with pathological diagnosis of small cell lung cancer components;
• 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;
• Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Lab values

• Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;

Other

• Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
• Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;

• 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.