A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer (B-F1RST)

April 15, 2020 updated by: Genentech, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93703
        • Veterans Affairs Central California Health Care System
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • St. Alexius Medical Center
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group; Canc Ctr at Blessing Hosp
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan St. Francis Health; Research Services
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Cancer Rsch Cons
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Inst
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Bronx, New York, United States, 10469
        • Eastchester Center for Cancer Care
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Cancer Treatment Centers of America - Eastern Regional Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute
    • Texas
      • Dallas, Texas, United States, 75390
        • Univ of Texas SW Medical Ctr
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Health Care Services
    • Washington
      • Lacey, Washington, United States, 98503
        • Western WA Oncology Inc PS
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Prior allogeneic bone marrow or solid organ transplant
  • Administration of a live, attenuated vaccine within 4 weeks prior to enrollment
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to enrollment
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab
Participants 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).
Drug: Atezolizumab
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).
Other Names:
  • MPDL3280A; RO5541267; Tecentriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator
Time Frame: Baseline up to 32 months
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
Time Frame: Baseline up to 32 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator
Time Frame: Baseline up to 32 months
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
Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator
Time Frame: Baseline up to 32 months
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.
Baseline up to 32 months
Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator
Time Frame: Baseline up to 32 months
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.
Baseline up to 32 months
Overall Survival (OS)
Time Frame: From baseline until death (up to 32 months)
OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
From baseline until death (up to 32 months)
Percentage of Participants With Adverse Events
Time Frame: Baseline up to 32 months
Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.
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
Time Frame: Months 6, 9, 12, and 18
A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.
Months 6, 9, 12, and 18
OS by Various bTMB Cutoff Points 16 and 20
Time Frame: From baseline until death (up to 32 months)
OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
From baseline until death (up to 32 months)
Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles
Time Frame: Baseline up to 32 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2016

Primary Completion (Actual)

May 14, 2019

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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