NCT04312308

A Study for Identification of Predictive Immune Biomarker for Atezolizumab Therapy in NSCLC Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The study aimed to elucidate predictive immune related biomarker to the responsiveness to the PD-L1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC patients during atezolizumab treatment.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Sample collection	1. .Analysis of immune marker using FACS before treatment and Cycle1, Cycle2, Cycle3 and the time of disease progression. 2. .Multiplexed biomarker analysis of tumor and immune cells in tumor microenvironment (TME) at pre-treatment and progression (Pre-treatment biopsy is mandatory but biopsy is optional for disease progression) 3\. microbiome Pretreatment stool sample will be collected. (Stool sample is optional) 4.Genetic analysis For RNAseq or exome seq, biopsied tissue at baseline or progression are optional. 4.Single cell RNA sequencing (scRNA-seq) scRNA-seq will be performed by collecting selectively tissues from pre-treatment tumor biopsies and at relapse/acquired resistance tumor biopsies. Screening and treatment biopsies are optional.

Timeline

• Start date: 2020-04-08
• Primary completion: 2025-01-26
• Completion: 2025-01-26
• First posted: 2020-03-18
• Last updated: 2026-02-06

Locations

1 site across 1 country: South Korea