About this trial
This is a single-arm study designed to evaluate the safety and efficacy of TILs combined with third-generation EGFR-TKIs therapy for patients with EGFR-mutant NSCLC resistant to TKI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1) Age 18-75 years, male or female; (2) Patients with a history of surgical resection, pathologically diagnosed with NSCLC, genetically tested for EGFR mutation, who experienced disease progression (local recurrence or distant metastasis) after EGFR-TKI treatment and refused chemotherapy or other therapies; (3) Ability to obtain approximately 5 tumor samples via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes; (4) ECOG performance status score of 0-2; (5) HGB ≥70 g/L, transfusion-eligible; (6) No severe hepatic, renal, cardiac, or pulmonary dysfunction, with the following requirements met: Creatinine ≤ 1.5 × ULN; Oxygen saturation > 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; (7) Expected survival > 3 months; complete clinical documentation.
Disqualifiers
(1) Patients with pathological diagnosis of small cell lung cancer components; (2) Patients who have previously undergone organ transplantation or cytoreductive therapy including lymph node clearance; (3) Patients currently receiving immunotherapy or steroid therapy; (4) Patients with concurrent severe or persistent infections that cannot be effectively controlled; (5) Patients with concurrent severe autoimmune diseases or congenital immunodeficiency; (6) History of severe allergic reactions to biological products (including antibiotics); (7) 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 lower limit of detection for the assay method); (8) HIV infection or syphilis infection; (9) Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months; (10) Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.
Trial design
Single group
Treatments tested in this trial
TILs infusion
DrugExperimental: 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
Treatment groups
Trial outcomes
Primary outcomes
According to the incidence of treatment-related adverse events (AEs) to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) combined with third-Generation EGFR-TKI therapy for TKI-Resistant advanced Non-Small Cell Lung Cancer (NSCLC)
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0.
Secondary outcomes
According to the subgroup analysis of TILs in patients with TKI-Resistant advanced NSCLC to analyze the correlation between TILs and disease prognosis.
TILs subgroup analysis Description: Composition, phenotype, and function of TILs
Other outcomes
According to the objective response rate (ORR) to evaluate the efficacy of TILs combined with third-Generation EGFR-TKI therapy for TKI-Resistant advanced NSCLC
Objective response rate (ORR) Description:The percentage of subjects with a Complete Response (CR) or Partial Response (PR) determined by RECIST 1.1 criteria.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: