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Completed

NCT Number: NCT02848651

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Veterans Affairs Central California Health Care System, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Acronym: B-F1RST

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2016
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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