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Non-Small Cell Lung CancerPhase 2B-F1RSTNCT02848651

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

A Phase 2 study testing Atezolizumab in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
20 sitesUnited States
Study dates
23 Sep 2016to 14 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Univ of Texas SW Medical Ctr

    Dallas, Texas, 75390

  • Inova Health Care Services

    Falls Church, Virginia, 22042

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Veterans Affairs Central California Health Care System

    Fresno, California, 93703

  • St. Alexius Medical Center

    Hoffman Estates, Illinois, 60169

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Franciscan St. Francis Health; Research Services

    Indianapolis, Indiana, 46237

  • Western WA Oncology Inc PS

    Lacey, Washington, 98503

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Virginia Piper Cancer Inst

    Minneapolis, Minnesota, 55407

  • Florida Hospital

    Orlando, Florida, 32803

  • Cancer Treatment Centers of America - Eastern Regional Medical Center

    Philadelphia, Pennsylvania, 19124

  • Quincy Medical Group; Canc Ctr at Blessing Hosp

    Quincy, Illinois, 62301

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Michigan Cancer Rsch Cons

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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

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.

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called MPDL3280A; RO5541267; Tecentriq

    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).

Study groups in NCT02848651
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants 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).
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator

    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.

    Measured: Baseline up to 32 months

  2. Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups

    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.

    Measured: Baseline up to 32 months

Secondary outcomes (8)

  1. Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator

    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.

    Measured: Baseline up to 32 months

  2. Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator

    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.

    Measured: Baseline up to 32 months

  3. Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator

    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.

    Measured: Baseline up to 32 months

  4. Overall Survival (OS)

    OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.

    Measured: From baseline until death (up to 32 months)

  5. Percentage of Participants With Adverse Events

    Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.

    Measured: Baseline up to 32 months

  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

    A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.

    Measured: Months 6, 9, 12, and 18

  7. OS by Various bTMB Cutoff Points 16 and 20

    OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.

    Measured: From baseline until death (up to 32 months)

  8. Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles

    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.

    Measured: Baseline up to 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study start23 Sep 2016
  3. Primary completion14 May 2019
  4. Study completion14 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02848651
Sponsor's protocol ID
ML39237
Acronym
B-F1RST
Status last verified
Apr 2020
First submitted
26 Jul 2016
Last updated
28 Apr 2020

Publications

  • Kim ES, Velcheti V, Mekhail T, Yun C, Shagan SM, Hu S, Chae YK, Leal TA, Dowell JE, Tsai ML, Dakhil CSR, Stella P, Jin Y, Shames DS, Schleifman E, Fabrizio DA, Phan S, Socinski MA. Blood-based tumor mutational burden as a biomarker for atezolizumab in non-small cell lung cancer: the phase 2 B-F1RST trial. Nat Med. 2022 May;28(5):939-945. doi: 10.1038/s41591-022-01754-x. Epub 2022 Apr 14.

    PubMed 35422531

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02848651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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