Atezolizumab and Stereotactic Body Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

Korábbi kezelés

• Uncontrolled concomitant disease
• Severe infection within 4 weeks prior to enrollment
• Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment
• Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
• Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter

Más betegség

• Active tuberculosis
• History of autoimmune disease
• Positive for human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen [HBsAg] reactive), or hepatitis C virus (hepatitis C virus ribonucleic acid [HCV RNA] [qualitative] is detected)
• History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia

Laborértékek

• Significant cardiovascular disease (New York Heart Association Class [NYHA] class II or greater); myocardial infarction within 3 month prior to randomization, unstable arrhythmias, unstable angina or a patient with a known left ventricular ejection fraction (LVEF) < 40%

Egyéb

• Pregnant and/or lactating women

• Histologically proven stage I NSCLC =< 5 cm diameter
• One or more high-risk features identified:
  • Tumor diameter >= 2 cm
  • Tumor standardized uptake value maximum (SUVmax) >= 6.2
  • Moderately, poorly differentiated or undifferentiated histology
• Evaluable disease per RECIST 1.1
• Patients must be medically or surgically inoperable as determined by a physician OR unwilling to undergo surgical resection
• All patients must have an forced expiratory volume in 1 second (FEV1) >= 700cc
• All patients must have a carbon monoxide diffusing capability test (DLCO) >= 5.5 m/min/mmHg
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
• Life expectancy >= 12 months
• Absolute neutrophil count (ANC) > 1500 cells/uL
• White blood cell count (WBC) > 2500/uL
• Lymphocyte count > 500/uL
• Platelet count > 100,000/uL
• Hemoglobin > 9 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) with alkaline phosphatase =< 2.5 x ULN OR AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN
• Serum bilirubin =< 1.0 x ULN
• International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to enrollment)
• Creatinine clearance > 30 mL/min by Cockcroft-Gault formula
• No history of severe hypersensitivity reactions to other monoclonal antibodies (mAbs)
• No other active malignancy
• Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible
• Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
• Archival tumor sample available; tissue from an fine-needle aspiration (FNA) is allowed but tumor tissue from a core needle biopsy is preferred
• For female patients of childbearing potential and male patients with partners of childbearing potential agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) and to continue its use for 6 months after the last dose of MPDL3280A
• Signed informed consent
• Ability to comply with the protocol