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

May 10, 2026 updated by: Suzhou BlueHorse Therapeutics Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial people's hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Li Wei, Prof. Dr. Med
          • Phone Number: 86-371-65897590
          • Email: wlixxt@163.com
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • The Third People's Hospital of Chengdu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Biological: PD-1 / PD-L1 monoclonal antibody
Received PD-1 antibody treatment according to the instructions.
Experimental: LM103 TILs Group
Biological: LM103 TILs Injection
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.
Experimental: LM103 TILs +PD-1/PD-L1 monoclonal Group
Biological: LM103 TILs Injection
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.
Biological: PD-1 / PD-L1 monoclonal antibody
Received PD-1 antibody treatment according to the instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Maximum 24~36 months
AEs will be recorded and assessed according to CTCAE Version 6.0
Maximum 24~36 months
Disease Free Survival
Time Frame: Every 12 weeks from treatment to 24~36 months
Based on pathological diagnosis or imaging results
Every 12 weeks from treatment to 24~36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
EORTC QLQ-C30
Time Frame: Every 12 weeks from treatment to 24~36 months
Every 12 weeks from treatment to 24~36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou BlueHorse Therapeutics Co., Ltd.

Investigators

  • Study Chair: Yilong Wu, Guangdong Provincial people's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM103-NSCLC-CT01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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