TILs Plus Third-Generation EGFR-TKI Therapy for TKI-Resistant NSCLC

NCT07498595 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: TILs TKI-SZ
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

EGFR-TKI-resistant Non-Small Cell Lung Cancer

Keywords

EGFR-TKI-resistant; TILs; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• According to the subgroup analysis of TILs in patients with TKI-Resistant advanced NSCLC to analyze the correlation between TILs and disease prognosis.

  Up to three months

Other Outcomes (1)

• 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

  Up to one year

Study Arms (1)

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

Drug: TILs infusion

Interventions

TILs infusion DRUG

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

This is a single-arm study of TILs combination with third-generation EGFR-TKIs therapy for NSCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share