This was a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Atezolizumab 1200 mg was administered by intravenous infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Veterans Affairs Central California Health Care System
Fresno, California, United States
Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator
Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.
Time frame: Baseline up to 32 months
Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups
Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.
Time frame: Baseline up to 32 months
Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator
Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.
Time frame: Baseline up to 32 months
Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator
Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first.
Time frame: Baseline up to 32 months
Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator
Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1.
Time frame: Baseline up to 32 months
Overall Survival (OS)
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Memorial Regional Hospital
Hollywood, Florida, United States
Florida Hospital
Orlando, Florida, United States
St. Alexius Medical Center
Hoffman Estates, Illinois, United States
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, United States
Franciscan St. Francis Health; Research Services
Indianapolis, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Michigan Cancer Rsch Cons
Ypsilanti, Michigan, United States
Virginia Piper Cancer Inst
Minneapolis, Minnesota, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
...and 10 more locations
OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
Time frame: From baseline until death (up to 32 months)
Percentage of Participants With Adverse Events
Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.
Time frame: Baseline up to 32 months
Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles
A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.
Time frame: Months 6, 9, 12, and 18
OS by Various bTMB Cutoff Points 16 and 20
OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
Time frame: From baseline until death (up to 32 months)
Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles
Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.
Time frame: Baseline up to 32 months