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A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer
Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-02-26
Completion Date
2028-12-31
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
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.
PD-1 / PD-L1 monoclonal antibody
Received PD-1 antibody treatment according to the instructions.
Locations (5)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China