NCT06287320

The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer

The Peripheral Blood Lymphocyte Subsets as Predicative Biomarkers Reflecting the Efficacy and Toxicity in Patients With Locally Advanced Non-small Cell Lung Cancer Received Chemoradiotherapy With or Without Immunotherapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).

Detailed description

All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection. The subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.

Conditions

• Locally Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	concurrent or sequential chemoradiotherapy	Thoracic radiation therapy(with the prescribed dose of 50-70 Gy), concurrently or sequentially combined with platinum-based doublet chemotherapy.
DRUG	Immunotherapy	anti-PD-1/anti-PD-L1 immune checkpoint inhibitors

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

1 site across 1 country: China