Lung cancer patients get a second chance: new cell combo aims to stop return of disease
NCT ID NCT07330037
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new treatment for people with a certain type of lung cancer (non-small cell lung cancer) who had surgery but still had cancer cells left. The treatment combines a cell therapy made from the patient's own immune cells (L-TIL) with an immunotherapy drug (tislelizumab). The goal is to see if this combination can keep the cancer from coming back. About 41 participants will be enrolled in this phase 2 trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Liquid tumor-infiltrating lymphocytes (L-TIL) and tislelizumab
- What this could lead to
- If this works, it could offer a new way to prevent lung cancer from coming back after surgery in patients who didn't fully respond to initial chemo-immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 41 participants, so results may not apply to everyone. The combination therapy may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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17 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; Exclusion Criteria: * 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; * 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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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- Can a targeted drug tame HER2-Mutant lung cancer?