NCT06479759

LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Multicenter Clinical Study of LM-108 Antibody in Combination With Sintilimab for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.

Detailed description

This study is an open-label, multi-cohort, multi-center clinical trial evaluating the efficacy, safety, and tolerability of LM-108 monoclonal antibody combined with sintilimab in treatment-naïve or previously treated subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). There are two cohorts in the study:(1)Cohort 1: NSCLC patients who developed secondary resistance after being sensitive to prior treatment with PD-1 inhibitors (monotherapy or in combination with another systemic therapy) for 6 months or more are eligible for this study.(2)Cohort 2: Patients with locally advanced or metastatic NSCLC who have not received prior systemic treatment are eligible for this study. Subjects in Cohort 1 will receive LM-108 monoclonal antibody combined with sintilimab. Subjects in Cohort 2 will receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained, and the choice of chemotherapy regimen and the duration of use will be determined by the investigator. Treatment will continue until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other investigator-determined reasons for discontinuation, whichever occurs first, with a maximum treatment duration of 24 months. The primary study endpoint is the objective response rate (ORR) assessed by the investigator based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Conditions

• NSCLC
• PD-1

Interventions

Type	Name	Description
DRUG	LM-108 antibody and sintilimab	Cohort 1 receive LM-108 monoclonal antibody combined with sintilimab
DRUG	LM-108 antibody and sintilimab and chemotherapy	Cohort 2 receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-06-12
• Completion: 2025-12-12
• First posted: 2024-06-28
• Last updated: 2024-06-28

Locations

1 site across 1 country: China