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Life expectancy 10 months |
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Histologically or cytologically confirmed stage IIIB or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous |
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No prior treatment for Stage IIIB or IV non-squamous NSCLC, with the following |
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exceptions |
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Patients with a sensitizing mutation in the EGFR gene must have experienced |
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disease progression or were intolerant to treatment with one or more EGFR |
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TKIs. Patients who have progressed on or were intolerant to first-line |
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osimertinib or other thirdgeneration EGFR TKIs are eligible |
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Patients who have progressed on or were intolerant to first- or second- |
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generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation |
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after TKI therapy are eligible |
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Patients who have progressed on or were intolerant to first- or second- |
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generation EGFR TKIs and who have evidence of the T790M mutation must have |
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also progressed on or were intolerant to osimertinib to be eligible |
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TKIs approved for treatment of NSCLC discontinued 7 days prior to enrollment |
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Measurable disease per RECIST v1.1. PD-L1 expression of 1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening |
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ECOG Performance Status of 0-1 |
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Adequate hematologic and end-organ function |
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Negative HIV test at screening |
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Negative hepatitis B surface antigen (HBsAg) test at screening |
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Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test |
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Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test |
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For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs |
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For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm |
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Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
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History of leptomeningeal disease
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Prior chemotherapy or other systemic therapy for stage IIIB/IV disease
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Active or history of autoimmune disease or immune deficiency
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History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
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Active tuberculosis
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Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
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History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
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Prior allogeneic stem cell or solid organ transplantation
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Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
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Current treatment with anti-viral therapy for HBV
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Treatment with investigational therapy within 28 days prior to initiation of study treatment
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Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
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Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
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Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
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History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
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Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations
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Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab
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Prior history of hypertensive crisis or hypertensive encephalopathy
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Significant vascular disease within 6 months prior to initiation of study treatment
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History of Grade 2 hemoptysis within 1 month prior to enrollment
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Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin, clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol
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Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for 2 weeks prior to enrollment
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History of stroke or transient ischemic attack within 6 months prior to enrollment
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Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
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History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to enrollment
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History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis,or colitis
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Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
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Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
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Proteinuria
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Clear tumor infiltration into the thoracic great vessels is seen on imaging
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Clear cavitation of pulmonary lesions is seen on imaging
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