A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer

NCT07444437 | Recruiting Phase 2

• 1 other identifier: LM103-NSCLC-CT01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief 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. The study will be followed up until 24 to 36 months after treatment.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AEs)

  AEs will be recorded and assessed according to CTCAE Version 6.0

  Maximum 24~36 months

• Disease Free Survival

  Based on pathological diagnosis or imaging results

  Every 12 weeks from treatment to 24~36 months

Study Arms (3)

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

Interventions

LM103 TILs Injection BIOLOGICAL

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.

LM103 TILs +PD-1/PD-L1 monoclonal Group; LM103 TILs Group

PD-1 / PD-L1 monoclonal antibody BIOLOGICAL

Received PD-1 antibody treatment according to the instructions.

Control Group; LM103 TILs +PD-1/PD-L1 monoclonal Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou BlueHorse Therapeutics Co., Ltd.: lead

Study Sites (5)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yilong Wu

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Yilong Wu, Prof. Dr. Med

CONTACT

86-20-83821484; gzyilong@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-02

Locations

CN (5)