[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631278":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":26,"armGroups":31,"interventions":38,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":43,"collaborators":26,"id":47,"slug":26,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":26,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Tianjin Medical University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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.","up to three years",[14],{"measure":15,"description":16,"timeFrame":17},"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","Up to three months",[19],{"measure":20,"description":21,"timeFrame":22},"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.","Up to one year",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":29,"maskingDescription":26,"whoMasked":26},"NONE","This study is an open-label, single-arm, prospective clinical trial. 50 subjects with advanced EGFR-TKI-resistant NSCLC, including those complicated with malignant pleural effusion, will be enrolled and receive TILs infusion combined with third-generation EGFR-TKIs. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up to systematically evaluate the safety and efficacy of this combined regimen.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"This is a single-arm study of TILs combination with third-generation EGFR-TKIs therapy for NSCLC","EXPERIMENTAL","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",[37],"Drug: TILs infusion",[39],{"type":40,"name":41,"description":35,"armGroupLabels":42,"otherNames":26},"DRUG","TILs infusion",[33],{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zuoqing Song","Chief Physician","100631278",false,"NCT07498595","TILs Plus Third-Generation EGFR-TKI Therapy for TKI-Resistant NSCLC","Safety Study of Tumor-Infiltrating Lymphocytes (TILs) Combined With Third-Generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy for TKI-Resistant Advanced Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* (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\u002FL, 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.\n\nExclusion Criteria:\n\n* (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.","ALL","18 Years","75 Years",{"count":57,"type":58},50,"ESTIMATED","INTERVENTIONAL",[61],"EARLY_PHASE1","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.",[64],"EGFR-TKI-resistant Non-Small Cell Lung Cancer",[66,67,68],"EGFR-TKI-resistant","TILs","Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-03-25",{"date":72,"type":73},"2026-03-27","ACTUAL",{"date":75,"type":58},"2026-03-31",{"date":77,"type":58},"2030-03-31",{"name":5,"class":6}]