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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02848651

Run by

Genentech, Inc.

People needed

153

Starts

2016-09-23

Expected to finish

2019-05-14

Last updated by the study team

2020-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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