EGFR-TKI-resistant Non-Small Cell Lung CancerEarly Phase 1NCT07498595
TILs Plus Third-Generation EGFR-TKI Therapy for TKI-Resistant NSCLC
A Early Phase 1 study testing TILs infusion in people with EGFR-TKI-resistant Non-Small Cell Lung Cancer, run by Tianjin Medical University General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EGFR-TKI-resistant Non-Small Cell Lung Cancer
- What is being tested?
- TILs infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 31 Mar 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- TILs infusion
- Keywords
- EGFR-TKI-resistant, TILs, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TILs infusionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: TILs infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
TILs subgroup analysis Description: Composition, phenotype, and function of TILs
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-TKI-resistant Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuoqing Song, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498595
- Sponsor's protocol ID
- TILs TKI-SZ
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07498595
- Acronym / sponsor ID
- TILs TKI-SZ
- Keywords
- EGFR-TKI-resistant, TILs, Non-Small Cell Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This is a single-arm study of TILs combination with third-generation EGFR-TKIs therapy for NSCLC | Experimental | Drug: TILs infusionExperimental: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TILs infusionExperimental: 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 | This is a single-arm study of TILs combination with third-generation EGFR-TKIs therapy for NSCLC |
Primary outcome
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)
Time frame: up to three years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0.
1 secondary outcome
According to the subgroup analysis of TILs in patients with TKI-Resistant advanced NSCLC to analyze the correlation between TILs and disease prognosis.
Time frame: Up to three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TILs infusion in people with EGFR-TKI-resistant Non-Small Cell Lung Cancer, run by Tianjin Medical University General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.