Non-Small Cell Lung CancerPhase 2NCT07444437
A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer
A Phase 2 study testing LM103 TILs Injection and PD-1 / PD-L1 monoclonal antibody in people with Non-Small Cell Lung Cancer, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 5 sites in China.
Trial summary
After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- LM103 TILs Injection and PD-1 / PD-L1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesChina
- Study dates
- 26 Feb 2026to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Received preoperative neoadjuvant therapy (including PD-1 antibody);
- Screening criteria:
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan
Yi Yang, 0086-28-61318530, csygcp@163.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yilong Wu, Prof. Dr. Med, 86-20-83821484, gzyilong@hotmail.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Wenzhao Zhong, Prof. Dr. Med, 86-20-83821484, 13609777314@163.com
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Guibin Qiao, 0086-20-62783374, zjyygcp@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Li Wei, Prof. Dr. Med, 86-371-65897590, wlixxt@163.com
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label, Phase IIa Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Adjuvant Treatment of Non-small Cell Lung Cancer With Negative Driver Gene Mutations
After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- LM103 TILs Injection, PD-1 / PD-L1 monoclonal antibody
- 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.
LM103 TILs InjectionBiological
Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment.
PD-1 / PD-L1 monoclonal antibodyBiological
Received PD-1 antibody treatment according to the instructions.
| Study group | Role | What they receive |
|---|---|---|
| LM103 TILs +PD-1/PD-L1 monoclonal Group | Experimental | Not described Receives: Biological: LM103 TILs Injection; Biological: PD-1 / PD-L1 monoclonal antibody |
| LM103 TILs Group | Experimental | Not described Receives: Biological: LM103 TILs Injection |
| Control Group | Active comparator | Not described Receives: Biological: PD-1 / PD-L1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
AEs will be recorded and assessed according to CTCAE Version 6.0
Measured: Maximum 24~36 months
Disease Free Survival
Based on pathological diagnosis or imaging results
Measured: Every 12 weeks from treatment to 24~36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start26 Feb 2026
- Primary completion31 Dec 2027 (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 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444437
- Sponsor's protocol ID
- LM103-NSCLC-CT01
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-label, Phase IIa Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Adjuvant Treatment of Non-small Cell Lung Cancer With Negative Driver Gene Mutations
- ClinicalTrials.gov ID
- NCT07444437
- Acronym / sponsor ID
- LM103-NSCLC-CT01
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 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.
After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LM103 TILs +PD-1/PD-L1 monoclonal Group | Experimental | Biological: LM103 TILs Injection, Biological: PD-1 / PD-L1 monoclonal antibody |
| LM103 TILs Group | Experimental | Biological: LM103 TILs Injection |
| Control Group | Active comparator | Biological: PD-1 / PD-L1 monoclonal antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Patients have lesions that can be used for surgical resection or biopsy puncture;
Key exclusion criteria (17 listed)
- 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;
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 |
|---|---|---|
| LM103 TILs InjectionExtract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment. | Biological | LM103 TILs +PD-1/PD-L1 monoclonal Group, LM103 TILs Group |
| PD-1 / PD-L1 monoclonal antibodyReceived PD-1 antibody treatment according to the instructions. | Biological | Control Group, LM103 TILs +PD-1/PD-L1 monoclonal Group |
Primary outcome
Adverse Events (AEs)
Time frame: Maximum 24~36 months
AEs will be recorded and assessed according to CTCAE Version 6.0
Disease Free Survival
Time frame: Every 12 weeks from treatment to 24~36 months
Based on pathological diagnosis or imaging results
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 13 May 2026.
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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.
Yilong Wu study chair
Guangdong Provincial People's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LM103 TILs Injection and PD-1 / PD-L1 monoclonal antibody in people with Non-Small Cell Lung Cancer, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 5 sites 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 10 inclusion and 17 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Yilong Wu, Prof. Dr. Med (86-20-83821484, gzyilong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Maximum 24~36 months). The study lists 2 primary outcomes in all. 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 13 May 2026.