Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02848651
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 5, 2019
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is 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 is to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 23, 2016
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Atezolizumab
Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression or loss of clinical benefit (up to approximately 3 years).
Drug: Atezolizumab
Atezolizumab 1200 mg will be administered by intravenous infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit (up to approximately 3 years).
Other Name: MPDL3280A; RO5541267; Tecentriq

Primary Outcome Measures :
  1. 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 approximately 3 years ]
  2. Progression-Free Survival (PFS) per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups [ Time Frame: Baseline up to approximately 3 years ]

Secondary Outcome Measures :
  1. PFS per RECIST v1.1 as Determined by Investigator [ Time Frame: Baseline up to approximately 3 years ]
  2. Duration of Response (DOR) per RECIST v1.1 as Determined by Investigator [ Time Frame: Baseline up to approximately 3 years ]
  3. Overall Survival (OS) [ Time Frame: From baseline until death (up to approximately 3 years) ]
  4. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]
  5. Percentage of Participants Who Are Alive and Progression-Free (per RECIST v1.1) at 6, 9, and 12 Months by Various bTMB Quantiles [ Time Frame: Months 6, 9, and 12 ]
  6. Percentage of Participants Who Are Alive (OS) at 6, 9, and 12 Months by Various bTMB Quantiles [ Time Frame: Months 6, 9, and 12 ]
  7. Percentage of Participants with Objective Response (per RECIST v1.1) by Various bTMB Quantiles [ Time Frame: Months 6, 9, and 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02848651

Hide Hide 22 study locations
Layout table for location information
United States, California
Veterans Affairs Central California Health Care System
Fresno, California, United States, 93703
Loma Linda Cancer Center
Loma Linda, California, United States, 92354
United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
St. Alexius Medical Center
Hoffman Estates, Illinois, United States, 60169
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, United States, 62301
United States, Indiana
Franciscan St. Francis Health; Research Services
Indianapolis, Indiana, United States, 46237
Investigative Clin Rsch of IN
Indianapolis, Indiana, United States, 46260
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Michigan
Michigan Cancer Rsch Cons
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Virginia Piper Cancer Inst
Minneapolis, Minnesota, United States, 55407
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Univ of Texas SW Medical Ctr
Dallas, Texas, United States, 75390
United States, Virginia
Inova Health Care Services
Falls Church, Virginia, United States, 22042
United States, Washington
Western WA Oncology Inc PS
Lacey, Washington, United States, 98503
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Genentech, Inc.
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Genentech, Inc. Identifier: NCT02848651    
Other Study ID Numbers: ML39237
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs