Could your own tumor cells stop lung cancer from returning?
NCT ID NCT07444437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment using a patient's own immune cells (called TILs) to prevent non-small cell lung cancer from returning after surgery. About 45 adults who have already had chemotherapy and surgery will be randomly assigned to receive either TILs plus standard care, TILs alone, or standard care alone. The goal is to see if TILs can keep cancer away longer and are safe.
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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 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 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: * At the date of signing Informed Consent Form (ICF), 18 \~75 years old, male or female; * Expected survival time \>3 months; * ECOG performance status 0-1; * Pathologically diagnosed as resectable non-small cell lung cancer: 1. Received preoperative neoadjuvant therapy (including PD-1 antibody); 2. Screening criteria: i. Driver gene mutations was negative; ii. No disease recurrence (including local recurrence) after surgery; iii. Expected to complete standard adjuvant therapy. * Patients have lesions that can be used for surgical resection or biopsy puncture; * Patients have sufficient hematology and organ functions; * Voluntarily sign a written informed consent form (ICF). Exclusion Criteria: * A history of other malignant tumors within the past 5 years, excluding malignant tumors that can be expected to heal after treatment (including but not limited to well-treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); * Adverse reactions caused by previous treatments have not been recovered to grade ≤1 (CTCAE V6.0) (excluding alopecia and neurotoxicity, and hypothyroidism, adrenal insufficiency and hypopituitarism that cannot be restored to grade 2 as determined by the investigators for a long time); * Any immune-related adverse reaction (irAE) with a severity level greater than grade 3 that has occurred during any previous immunotherapy and has been permanently discontinued; * Have received vaccination within two months prior to signing the ICF, or plan to receive vaccination during the study; * Have received TIL cell therapy, allogeneic T cell therapy or NK cell therapy within 6 months prior to signing the ICF; * Have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past; * Suffering from or suspected of having an active autoimmune disease; * Suffering from a large amount of pleural effusion or ascites with clinical symptoms or requiring symptomatic treatment; * Patients with current or previous irreversible interstitial lung disease; * Suffering from serious cardiovascular and cerebrovascular diseases; * Suffering from an active infection that requires systemic treatment; * Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS; * Patients with esophageal or gastric varices requiring immediate intervention (such as ligation or sclerotherapy), or those with a higher risk of bleeding as recommended by the investigator or gastroenterologist or hepatologist, evidence of portal hypertension (including splenomegaly found in imaging examinations), or a history of variceal bleeding must undergo endoscopic assessment within 3 months before enrollment; * Uncontrolled metabolic disorders, such as diabetes, or other non-malignant organ or systemic diseases or secondary reactions to cancer, can lead to higher medical risks and/or uncertainties in survival assessment; * Those who are known to be allergic to any component of the investigational drug and the LM103 product formula; * Women who are pregnant or breastfeeding; * As determined by the investigators, there are other severe, acute or chronic medical diseases, mental disorders or laboratory abnormalities that may increase the risks related to participation in the study or may interfere with the interpretation of the study results.
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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
5 sites. 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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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, Guangdong, China
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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, Guangdong, China
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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, China
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The Third People's Hospital of Chengdu
NOT_YET_RECRUITINGChengdu, Sichuan, China
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Zhujiang Hospital of Southern Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink advanced solid tumors?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug shrink tumors that resist standard care?
- Can a Three-Dose immunotherapy cure early lung cancer without surgery?
- Can a new drug shrink advanced solid tumors?
- Can a less extensive lung cancer surgery be just as effective?