Experimental Immunotherapy MPDL3280A (Atezolizumab) and Radiation to treat patients with lung cancer

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"Study of Experimental Immunotherapy (Atezolizumab) and high dose radiation (SAR) in Inoperable Stage 1 Non-Small Cell Lung Cancer"
18 to 100 years old
Healthy Volunteers:
lung, lung cancer, immunotherapy, radiation, Inoperable Stage I lung cancer
Drug study, Phase 1
This study will be looking at the combination of a type of radiation treatment called “stereotactic ablative therapy” and an experimental drug called MPDL3280A (Atezolizumab).
Stereotactic ablative radiotherapy (referred to throughout this consent form as “SAR”), also known as stereotactic body radiation therapy (SBRT), is a newer radiation treatment that delivers fewer but higher doses of radiation than standard radiation. (Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors) It uses special equipment to position the patient and guide focused beams toward the cancer and away from normal surrounding lung tissue. The higher dose technique may work better to kill cancer cells potentially with fewer side effects than standard radiation therapy.
MPDL3280A (Atezolizumab) (the study drug) is an antibody (a protein produced by the body's immune system) that affects the immune system by blocking the programmed death-ligand 1 (“PD-L1”) pathway. The PD-L1 pathway is involved in regulating the body’s natural immune response, but tumors can take advantage of this regulation to partially fight or ignore the immune system. By blocking the PD L1 pathway, the study drug may help your immune system stop or reverse the growth of tumors.
While SAR is a standard treatment for your cancer, the study drug is an experimental drug, which means that the FDA (Food and Drug Administration) and other health authorities have not approved the study drug for the treatment of NSCLC or any other cancer. Researchers hope that combining the study drug with SAR will increase the effect on your body’s immune system to fight your cancer.
This study requires

History and Physical Blood tests Tumor sample (from biopsy at diagnosis) CT/MRIs SAR IV study medication

Who can participate

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Uncontrolled concomitant disease

  • 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%

  • Severe infection within 4 weeks prior to enrollment

  • Active tuberculosis

  • Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment

  • 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

  • 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

  • Pregnant and/or lactating women

Study duration and period
Recruitment period
From Sept. 29, 2015
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Research Topic
  • Stage I Non-Small Cell Lung Cancer

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