Primary Early-stage Non-small Cell Lung CancerEarly Phase 1NCT07498439
TILs Therapy for Multiple Primary Early-Stage NSCLC
A Early Phase 1 study testing TILs injection in people with Primary Early-stage Non-small Cell Lung Cancer, run by Tianjin Medical University General Hospital.
Trial summary
This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Early-stage Non-small Cell Lung Cancer
- What is being tested?
- TILs injection
- 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
- Age 18-75 years, male or female;
- Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation;
- Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments;
- Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;
- ECOG performance status score of 0-2;
- HGB ≥70 g/L, transfusion-eligible;
Show all 9Show fewer
- No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria:
- Creatinine ≤ 1.5 × ULN; Oxygen saturation > 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
- Estimated survival > 5 years with complete clinical documentation.
Who cannot join
- Patients with pathological diagnosis of small cell lung cancer components;
- Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
- Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;
- Patients currently undergoing steroid therapy;
- Concurrent severe or persistent infections unresponsive to effective control;
- Concurrent severe autoimmune disease or congenital immunodeficiency;
Show all 11Show fewer
- History of severe allergic reactions to biological products (including antibiotics);
- 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 assay method's lower limit of detection);
- HIV infection or syphilis infection;
- Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;
- 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) Therapy for Multifocal Early-Stage Non-Small Cell Lung Cancer (NSCLC)
This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC
Read the detailed description
This study is an open-label, single-arm, prospective clinical trial. 50 subjects with multiple primary early-stage non-small cell lung cancer (NSCLC), including those with malignant pleural effusion, will be enrolled and administered with tumor-infiltrating lymphocytes (TILs) injection therapy. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up, so as to systematically evaluate the safety and effectiveness of TILs treatment for multiple
- Being tested
- TILs injection
- Keywords
- TILs, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TILs injectionDrug
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 |
|---|---|---|
| A single-arm TILs treatment | 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 injection |
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) therapy for multiple primary early-stage 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 multiple primary early-stage 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 Primary Early-stage 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
- NCT07498439
- Sponsor's protocol ID
- TILs NSCLC-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) Therapy for Multifocal Early-Stage Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07498439
- Acronym / sponsor ID
- TILs NSCLC-SZ
- Keywords
- TILs, NSCLC
- 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 aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC
Detailed description
This study is an open-label, single-arm, prospective clinical trial. 50 subjects with multiple primary early-stage non-small cell lung cancer (NSCLC), including those with malignant pleural effusion, will be enrolled and administered with tumor-infiltrating lymphocytes (TILs) injection therapy. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up, so as to systematically evaluate the safety and effectiveness of TILs treatment for multiple
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-arm TILs treatment | Experimental | Drug: TILs injectionExperimental: 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 (9 listed)
- Age 18-75 years, male or female;
- Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation;
- Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments;
- Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;
- ECOG performance status score of 0-2;
Key exclusion criteria (11 listed)
- Patients with pathological diagnosis of small cell lung cancer components;
- Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
- Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;
- Patients currently undergoing steroid therapy;
- Concurrent severe or persistent infections unresponsive to effective control;
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 injectionExperimental: 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 | A single-arm TILs treatment |
Primary outcome
According to the incidence of treatment-related adverse events（AEs）to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) therapy for multiple primary early-stage 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 multiple primary early-stage 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
Related trials for Primary Early-stage Non-small Cell Lung Cancer
Not yet recruiting
Percutaneous Pulsed Electric Field Ablation for Early-Stage NSCLC and Lung Oligometastases: A Safety and Efficacy Study
Lung Cancer (NSCLC)
RecruitingObservational study
Multi-omics Study of Early-stage Lung Cancer With Distinct Phenotypes
Lung Cancer Associated With Cystic Airspaces, Multiple Primary Lung Cancers
Active, not recruitingPhase 1/2
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
Non-Small Cell Lung Cancer, Medullary Thyroid Cancer
RecruitingPhase 1/2
Synapse 3D With Intravascular Indocyanine Green
Non-small Cell Lung Cancer, Primary Neoplasm
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 injection in people with Primary Early-stage 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 9 inclusion and 11 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) therapy for multiple primary early-stage 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.