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

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ClinicalTrials.gov Identifier: NCT02848651
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE September 23, 2016
Actual Primary Completion Date May 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
  • 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: Up to approximately 28 months ]
  • Progression-free Survival (PFS) per RECIST v1.1 by Circulating Blood-based Tumor Biomarkers [ Time Frame: Up to approximately 28 months ]
Change History Complete list of historical versions of study NCT02848651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • PFS per RECIST v1.1 as Determined by Investigator [ Time Frame: Baseline up to approximately 3 years ]
  • Duration of Response (DOR) per RECIST v1.1 as Determined by Investigator [ Time Frame: Baseline up to approximately 3 years ]
  • Overall Survival (OS) [ Time Frame: From baseline until death (up to approximately 3 years) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]
  • 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 ]
  • Percentage of Participants Who Are Alive (OS) at 6, 9, and 12 Months by Various bTMB Quantiles [ Time Frame: Months 6, 9, and 12 ]
  • Percentage of Participants with Objective Response (per RECIST v1.1) by Various bTMB Quantiles [ Time Frame: Months 6, 9, and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
  • PFS per RECIST v1.1 as Determined by Investigator [ Time Frame: Up to approximately 28 months ]
  • Duration of Response (DOR) per RECIST v1.1 as Determined by Investigator [ Time Frame: Up to approximately 28 months ]
  • Overall Survival (OS) [ Time Frame: From baseline until death (Up to approximately 28 months) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 28 months ]
  • Percentage of Participants Who Were Alive and Progression-free (PFS) at 6, 9, and 12 Months by Blood-based Tumor Biomarkers [ Time Frame: Months 6, 9, and 12 ]
  • Percentage of Participants Who Were Alive (OS) at 6, 9, and 12 Months by Blood-based Tumor Biomarkers [ Time Frame: Months 6, 9, and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
153
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
150
Actual Study Completion Date  ICMJE May 14, 2019
Actual Primary Completion Date May 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848651
Other Study ID Numbers  ICMJE ML39237
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP