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.
Atezolizumab is approved as the treatment of patients with locally advanced or metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy by the Ministry of Food and Drug Safety (MFDS) and the treatment is available on the National Health Insurance Service in South Korea. Patients will be treated with atezolizumab until loss of clinical benefit or unmanageable toxicity as routine practice. In this study, the investigators will register patients who have a plan to be treated with atezolizumab as MFDS approval condition and meet study inclusion and exclusion criteria. The investigators will collect study related information during routine practice and collect blood and/or tissue(optional) samples to conduct the study. Tumor assessment will be performed by investigator on the base of RECIST (version 1.1) and related information will be collected until disease progression for patients who have discontinued treatment. However, it will be collected until treatment discontinuation for patients who continue to receive atezolizumab following initial disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Blood sampling will be performed before and after 3rd cycle of atezolizumab for evaluation of tumor mutation burden
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Objective response rate (ORR)
ORR between blood TMB-High vs. Low group
Time frame: At the end of cycle 3 (each cycle is 21 days)
Progression-free survival (PFS)
PFS in Intention-to-treat (ITT) population and subgroups according to blood TMB and programmed cell death-1 (PDL1) status
Time frame: At the end of cycle 3 (each cycle is 21 days)
Safety profile
Incidence of Treatment-related Adverse Events as assessed by CTCAE version 4
Time frame: Through study completion, an average of 1 year
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