A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT02848651
Last Updated: 2020-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2016-09-23
2019-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Veterans Affairs Central California Health Care System
Fresno, California, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Florida Hospital
Orlando, Florida, United States
St. Alexius Medical Center
Hoffman Estates, Illinois, United States
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, United States
Franciscan St. Francis Health; Research Services
Indianapolis, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Michigan Cancer Rsch Cons
Ypsilanti, Michigan, United States
Virginia Piper Cancer Inst
Minneapolis, Minnesota, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Univ of Texas SW Medical Ctr
Dallas, Texas, United States
Inova Health Care Services
Falls Church, Virginia, United States
Western WA Oncology Inc PS
Lacey, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ML39237
Identifier Type: -
Identifier Source: org_study_id
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