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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.
 
ClinicalTrials.gov Identifier: NCT02848651
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
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

Arms and Interventions
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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 Name: MPDL3280A; RO5541267; Tecentriq


Outcome Measures
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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 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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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.


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02848651


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:
Study Protocol  [PDF] April 29, 2019
Statistical Analysis Plan  [PDF] January 17, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02848651    
Other Study ID Numbers: ML39237
First Posted: July 28, 2016    Key Record Dates
Results First Posted: April 28, 2020
Last Update Posted: April 28, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents