A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer
B-F1RST
A Phase II Single-Arm Study of Atezolizumab Monotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Clinical Evaluation of Novel Blood-Based Diagnostics
1 other identifier
interventional
153
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Sep 2016
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Start
First participant enrolled
September 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2019
CompletedResults Posted
Study results publicly available
April 28, 2020
CompletedApril 28, 2020
April 1, 2020
2.6 years
July 26, 2016
April 15, 2020
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline up to 32 months
Secondary Outcomes (8)
Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator
Baseline up to 32 months
Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator
Baseline up to 32 months
Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator
Baseline up to 32 months
Overall Survival (OS)
From baseline until death (up to 32 months)
Percentage of Participants With Adverse Events
Baseline up to 32 months
- +3 more secondary outcomes
Study Arms (1)
Atezolizumab
EXPERIMENTALParticipants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Interventions
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).
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed Stage IIIB-IVB NSCLC
- For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment
- Participants with any programmed death-ligand 1 (PD-L1) test result by immunohistochemistry (IHC) are eligible for the study
- Participants without a PD-L1 test result are eligible for the study
- Measurable disease per RECIST v1.1
- Adequate hematologic and end-organ function
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods among women of childbearing potential
You may not qualify if:
- Prior treatment with immunotherapy for any stage NSCLC, including early-stage (neoadjuvant or adjuvant) disease
- Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and anaplastic lymphoma kinase (ALK) rearrangements
- Active central nervous system (CNS) metastases requiring treatment
- Spinal cord compression not definitively treated or not clinically stable
- Leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage procedures
- Uncontrolled or symptomatic hypercalcemia
- Malignancies other than NSCLC within 5 years prior to enrollment, except for those curatively treated with negligible risk of metastasis or death
- Pregnant or lactating women
- History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease
- Positive human immunodeficiency virus (HIV) or hepatitis B or C
- Active tuberculosis
- Severe infection or major surgery within 4 weeks, or oral or IV antibiotics treatment within 2 weeks prior to enrollment
- Prior treatment with or hypersensitivity to study drug or related compounds
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (20)
Veterans Affairs Central California Health Care System
Fresno, California, 93703, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Florida Hospital
Orlando, Florida, 32803, United States
St. Alexius Medical Center
Hoffman Estates, Illinois, 60169, United States
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, 62301, United States
Franciscan St. Francis Health; Research Services
Indianapolis, Indiana, 46237, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Michigan Cancer Rsch Cons
Ypsilanti, Michigan, 48197, United States
Virginia Piper Cancer Inst
Minneapolis, Minnesota, 55407, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Eastchester Center for Cancer Care
The Bronx, New York, 10469, United States
Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Univ of Texas SW Medical Ctr
Dallas, Texas, 75390, United States
Inova Health Care Services
Falls Church, Virginia, 22042, United States
Western WA Oncology Inc PS
Lacey, Washington, 98503, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
Kim ES, Velcheti V, Mekhail T, Yun C, Shagan SM, Hu S, Chae YK, Leal TA, Dowell JE, Tsai ML, Dakhil CSR, Stella P, Jin Y, Shames DS, Schleifman E, Fabrizio DA, Phan S, Socinski MA. Blood-based tumor mutational burden as a biomarker for atezolizumab in non-small cell lung cancer: the phase 2 B-F1RST trial. Nat Med. 2022 May;28(5):939-945. doi: 10.1038/s41591-022-01754-x. Epub 2022 Apr 14.
PMID: 35422531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2016
First Posted
July 28, 2016
Study Start
September 23, 2016
Primary Completion
May 14, 2019
Study Completion
May 14, 2019
Last Updated
April 28, 2020
Results First Posted
April 28, 2020
Record last verified: 2020-04