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A Study of Atezolizumab (MPDL3280A) as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): Clinical Evaluation of Novel Blood-Based Diagnostics (B-F1RST)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02848651
First received: July 26, 2016
Last updated: September 5, 2017
Last verified: September 2017
  Purpose
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 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 Intervention Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Actual Study Start Date: September 23, 2016
Estimated Study Completion Date: June 9, 2020
Estimated Primary Completion Date: June 9, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02848651

Contacts
Contact: Reference Study ID Number: ML39237 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 24 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02848651     History of Changes
Other Study ID Numbers: ML39237
Study First Received: July 26, 2016
Last Updated: September 5, 2017

Additional relevant MeSH terms:
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017