NCT07444437

LM103 in Phase IIa Clinical Trial for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-26
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

3 sites across 1 country: China