[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631278":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":19,"responsibleParty":20,"collaborators":19,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":19,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":19,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":43,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":19},{"fullName":5,"class":6},"Tianjin Medical University General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Drug: TILs infusion",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","TILs infusion",[9],null,{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Zuoqing Song","Chief Physician","100631278","early-phase-1-tils-plus-third-generation-egfr-tki-therapy-for-tki-resistant-nsclc-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":35,"type":36},50,"ESTIMATED","INTERVENTIONAL",[39],"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.",[42],"EGFR-TKI-resistant Non-Small Cell Lung Cancer",[44,45,46],"EGFR-TKI-resistant","TILs","Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-03-25",{"date":50,"type":51},"2026-03-27","ACTUAL",{"date":53,"type":36},"2026-03-31",{"date":55,"type":36},"2030-03-31",{"name":5,"class":6}]