NCT04858828

Investigation on Predictive Molecular Markers of Efficacy for Front-line Immunochemotherapy in Advanced NSCLC

Investigation on Molecular Markers Associated With the Clinical Efficacy of Immunotherapy Combined With Chemotherapy in the First-line Treatment of Patients With Advanced Non-small-cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Zhou Chengzhi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This project is a real-world exploratory study aiming to explore potential molecular markers detectable at baseline that can enable the prediction of clinical efficacy of front-line immunotherapy combined with chemotherapy in advanced non-small cell lung cancer (NSCLC). This study aims to include a total of 200 treatment-naïve patients initially diagnosed with advanced NSCLC. Paired tissue and blood samples collected from all patients before the start of immunochemotherapy treatment (baseline) will be analyzed. The patient samples will be submitted for molecular analysis, including next-generation sequencing (NGS)-based gene expression profiling (GEP) and inflammation-related T-cell receptor (TCR) repertoire profiling. The molecular assay results will include but will not be limited to tumor mutation burden (TMB), microsatellite instability (MSI) status, DNA damage repair (DDR)-related gene mutation status, and programmed death-ligand 1 (PD-L1) expression level. Patients will be followed-up for treatment responses until radiological confirmation of disease progression to first-line immunochemotherapy. The molecular assay results will then be analyzed with clinical data including objective responses and progression-free survival outcomes, among others, to identify molecular markers at baseline that are associated with clinical efficacy of immunochemotherapy.

Conditions

• Biomarkers

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-03-01
• Completion: 2024-03-01
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: China