NSCLCPhase 2NCT07330037
TALENT Study: Phase II Trial of Adjuvant L-TIL Plus Tislelizumab in Resectable NSCLC Without pCR After Neoadjuvant Chemoimmunotherapy
A Phase 2 study testing L-TIL cells injection and Tislelizumab in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study evaluates the preliminary efficacy and safety of adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC) who underwent surgery after neoadjuvant treatment with an immune checkpoint… Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- L-TIL cells injection and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2028
- Phase
- Phase 2
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC with imaging indicating resectable stage II-IIIB (N2) disease according to the ninth edition of the AJCC lung cancer TNM staging system;
- No prior anti-tumor treatment;
- Negative for EGFR/ALK/ROS1 mutations;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Undergone 2-4 cycles of neoadjuvant therapy combining immunotherapy and chemotherapy, followed by surgical resection with R0 margins but without achieving a complete pathological response (non-pCR);
- Adequate organ function as defined below (without using any blood products or hematopoietic growth factors within 14 days):
- Normal bone marrow reserve: neutrophil count ≥1.5×10⁹/L, lymphocyte count ≥0.6×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90g/L; Normal renal function: serum creatinine ≤1.5 mg/dL and/or creatinine clearance rate ≥60 mL/min; Normal liver function: total bilirubin ≤1.5 times ULN, AST and ALT ≤1.5 times ULN; Normal coagulation function: APTT ≤1.5 times ULN, INR ≤1.5 times ULN, PT ≤1.5 times ULN; Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; Pulmonary function test showing FEV1 ≥60%;
- For non-surgically sterilized or women of childbearing potential, must agree to use medically approved contraception (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of treatment; must have a negative serum or urine HCG test within 7 days prior to study entry; must not be breastfeeding;
Who cannot join
- Vaccination within 28 days prior to the first dose, except for inactivated vaccines;
- Major surgery within 28 days prior to the first dose;
- History of other malignancies within 5 years prior to screening;
- Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (for inclusion criteria, ALT and AST levels must be within specified limits; for hepatitis B: HBV DNA >10^4/ml; for hepatitis C: HCV RNA >10^3/ml; for chronic hepatitis B carriers, HBV DNA >2000 IU/ml (>10^4 copies/ml), antiviral treatment must be concurrently administered during the study period);
- Unstable or severe concurrent diseases within 6 months prior to the first dose, such as severe/unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, pulmonary hypertension, life-threatening ventricular arrhythmias requiring maintenance therapy, stroke, and uncontrolled severe seizures;
- Clinically significant active pneumonia or other respiratory system diseases severely affecting lung function at screening;
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- Active autoimmune diseases, history of autoimmune diseases, or conditions requiring systemic corticosteroids or immunosuppressive drugs;
- Arterial or venous thrombotic events occurring within 6 months prior to screening;
- History or CT findings indicating active tuberculosis within 1 year prior to enrollment that was untreated;
- Active infections requiring systemic anti-infective treatment;
- Active gastrointestinal bleeding or contraindications to IL-2 use;
- Previous bone marrow transplant or solid organ transplant;
- Other serious acute or chronic medical or psychiatric illnesses (including suicidal ideation or behavior within one year) that may increase the risk associated with participation in the study or administration of the investigational treatment, interfere with the investigational treatment and follow-up, or affect the subject's compliance;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Liang Liu, MD. Ph.D, +86-22-23340123-6417, liuliang@tjmuch.com
About this study
Official title: A Prospective Phase II Clinical Trial Evaluating Liquid Tumor-infiltrating Lymphocytes (L-TIL) in Combination With Tislelizumab as Adjuvant Therapy in Patients With Resectable Stage II to IIIB (N2) Non-small Cell Lung Cancer (NSCLC) Who Have Undergone Surgery Following Neoadjuvant Treatment With an Immune Checkpoint Inhibitor Plus Platinum-based Doublet Chemotherapy and Did Not Achieve a Pathological Complete Response (pCR)
This study evaluates the preliminary efficacy and safety of adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC) who underwent surgery after neoadjuvant treatment with an immune checkpoint inhibitor plus platinum-based doublet chemotherapy but did not achieve a pathological complete response (pCR).
- Conditions
- NSCLC
- Being tested
- L-TIL cells injection, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-TIL cells injectionBiological
Autologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion.
TislelizumabDrug
Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| L-TIL Cells Plus Tislelizumab | Experimental | Participants will receive adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab. Autologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion. Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment. Receives: Biological: L-TIL cells injection; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease Free Survival
2-year DFS is defined as the proportion of patients who remain free of disease recurrence, second primary malignancy, or death from any cause at 24 months after surgery.
Measured: 2 years
Secondary outcomes (6)
Disease free survival (DFS)
DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first.
Measured: Up to 3 years
Overall survival (OS)
OS defined as the time from the date of randomization to the date of death due to any cause, in Stage II-IIIB and in Stage IB-IIIB
Measured: Up to 5 years
Adverse event (AE)
Incidence and severity of AEs, with severity as determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Measured: Up to 5 years
Locoregional Recurrence-Free Survival (LRFS)
LRFS was calculated from the date of surgery to the date of first locoregional recurrence; patients without such an event were censored at the date of last follow-up or death.
Measured: Up to 3 years
Distant Metastasis-Free Survival (DMFS)
DMFS was measured from the date of surgery to the date of first distant metastasis; patients without distant metastasis were censored at the last follow-up or at death, whichever occurred first.
Measured: Up to 3 years
Lung Cancer-Specific Survival (LCSS)
Lung cancer-specific survival (LCSS) was calculated from the date of surgery to the date of death due to lung cancer; deaths from other causes were censored at the time of death.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330037
- Sponsor's protocol ID
- TALENT
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Trial Evaluating Liquid Tumor-infiltrating Lymphocytes (L-TIL) in Combination With Tislelizumab as Adjuvant Therapy in Patients With Resectable Stage II to IIIB (N2) Non-small Cell Lung Cancer (NSCLC) Who Have Undergone Surgery Following Neoadjuvant Treatment With an Immune Checkpoint Inhibitor Plus Platinum-based Doublet Chemotherapy and Did Not Achieve a Pathological Complete Response (pCR)
- ClinicalTrials.gov ID
- NCT07330037
- Acronym / sponsor ID
- TALENT
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jan 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 study evaluates the preliminary efficacy and safety of adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC) who underwent surgery after neoadjuvant treatment with an immune checkpoint inhibitor plus platinum-based doublet chemotherapy but did not achieve a pathological complete response (pCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-TIL Cells Plus Tislelizumab | Experimental | Biological: L-TIL cells injection, Drug: TislelizumabParticipants will receive adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab. Autologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion. Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed NSCLC with imaging indicating resectable stage II-IIIB (N2) disease according to the ninth edition of the AJCC lung cancer TNM staging system;
- No prior anti-tumor treatment;
- Negative for EGFR/ALK/ROS1 mutations;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Undergone 2-4 cycles of neoadjuvant therapy combining immunotherapy and chemotherapy, followed by surgical resection with R0 margins but without achieving a complete pathological response (non-pCR);
Key exclusion criteria (13 listed)
- Vaccination within 28 days prior to the first dose, except for inactivated vaccines;
- Major surgery within 28 days prior to the first dose;
- History of other malignancies within 5 years prior to screening;
- Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (for inclusion criteria, ALT and AST levels must be within specified limits; for hepatitis B: HBV DNA >10^4/ml; for hepatitis C: HCV RNA >10^3/ml; for chronic hepatitis B carriers, HBV DNA >2000 IU/ml (>10^4 copies/ml), antiviral treatment must be concurrently administered during the study period);
- Unstable or severe concurrent diseases within 6 months prior to the first dose, such as severe/unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, pulmonary hypertension, life-threatening ventricular arrhythmias requiring maintenance therapy, stroke, and uncontrolled severe seizures;
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 |
|---|---|---|
| L-TIL cells injectionAutologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion. | Biological | L-TIL Cells Plus Tislelizumab |
| TislelizumabTislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment. | Drug | L-TIL Cells Plus Tislelizumab |
Primary outcome
2-year Disease Free Survival
Time frame: 2 years
2-year DFS is defined as the proportion of patients who remain free of disease recurrence, second primary malignancy, or death from any cause at 24 months after surgery.
6 secondary outcomes
Disease free survival (DFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 5 years
Adverse event (AE)
Time frame: Up to 5 years
Locoregional Recurrence-Free Survival (LRFS)
Time frame: Up to 3 years
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to 3 years
Lung Cancer-Specific Survival (LCSS)
Time frame: Up to 5 years
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 9 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-TIL cells injection and Tislelizumab in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Dongsheng Yue, MD. Ph.D (+86-22-23340123-6417, yuedongsheng_cg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease Free Survival (time frame: 2 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 9 Jan 2026.