CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 45 target
Drug / intervention
LM103 TILs Injection +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07444437
NCT07444437Phase 2RecruitingOn Track

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

Suzhou BlueHorse Therapeutics Co., Ltd.·interventional·Posted Mar 3, 2026·Updated May 13, 2026

In Brief

A Phase 2 clinical trial evaluating LM103 TILs Injection and PD-1 / PD-L1 monoclonal antibody for Non-Small Cell Lung Cancer. Currently recruiting, targeting 45 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202720282029
First PostedMar 3, 2026
Enrollment StartFeb 26, 2026
Primary CompletionDec 31, 2027
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 4 months agoPrimary completion in 1.5 years

Interventions

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.