A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/21/2019 |
Start Date: | September 23, 2016 |
End Date: | June 28, 2019 |
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 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.
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.
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
We found this trial at
22
sites
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1021 Morehead Medical Drive
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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2615 East Clinton Avenue
Fresno, California 93703
Fresno, California 93703
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Florida Hospital Florida Hospital is one of the country
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Philadelphia, Pennsylvania 19124
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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