A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients

Exclusion Criteria

• •Involvement in the planning and/or conduct of the study; previous enrollment in the present study.
• •Participation in another clinical study with an investigational product for cancer during the last 12 months.
• •Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
• •Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids in excess of prednisone 10 mg/d or equivalent.
• •Sensitizing mutations in EGFR or rearrangements in ALK or ROS1.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab.
• •Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.
• •Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids . Patients may be on systemic corticosteroids provided the dose does not exceed prednisone 10 mg/d or equivalent for 1 week prior to study drug administration.
• •Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• •Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• •History of primary immunodeficiency.
• •History of allogeneic organ transplant.
• •Uncontrolled intercurrent illness.
• •Known history of previous clinical diagnosis of tuberculosis.
• •History of leptomeningeal carcinomatosis.
• •Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
• •Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
• •Subjects with uncontrolled seizures.
• •Pregnant women; breastfeeding should be discontinued.
• •Prior history of radiation pneumonitis.