Evaluation of Blood TMB for the Efficacy of Atezolizumab [BUDDY]

Sponsor
Chonnam National University Hospital
Study ID
NCT04059887
Phase
PHASE4
Status
Completed

Conditions

  • Lung Neoplasm Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is single arm, prospective, multi-center, cohort study to evaluate blood TMB for improved efficacy of atezolizumab in locally advanced or metastatic NSCLC at the study enrollment who failed one or more prior lines of chemotherapy including at least 1 platinum-based.

Key Dates

Start date
Dec 18, 2019
Status verified
Feb 2023
Primary completion
Dec 31, 2021
Completion
Jun 30, 2022

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Atezolizumab
    Atezolizumab 1200 mg will be administrated every 3 week cycle

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: At the end of cycle 3 (each cycle is 21 days) ]

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