Study of AZD9291 plus MEDI4736 versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours - CAURAL

Exclusion Criteria

• - Treatment with an EGFR-TKI within 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; current treatment with potent inhibitors/inducers of cytochrome P450 3A4 (CYP3A4); previous treatment with AZD9291 (or other agents specifically targeted against EGFR T790M mutation positive NSCLC); Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months of starting 1st EGFR TKI treatment; prior exposure to immune-mediated therapy including, but not limited to, other anti cytotoxic T–lymphocyte-associated antigen 4 (anti CTLA-4), anti- programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 (anti-PD-L1), and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks; major surgery within 4 weeks;
• - Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736 (excluding intranasal, inhaled, topical steroids, or local steroid injections)
• - Unresolved toxicities from prior therapy
• - History of active primary immunodeficiency
• - Unstable brain metastases or spinal cord compression
• - Severe/uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, bleeding diatheses or infection
• - Cardiac disease
• - Ophthalmological conditions
• - Refractory nausea/vomiting, chronic gastrointestinal diseases or bowel resection
• - Past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
• - History of another primary malignancy
• - Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
• - History of organ transplant that requires use of immunosuppressive medications
• - Known history of tuberculosis
• - Receipt of live, attenuated vaccine within 30 days prior to the first dose of MEDI4736
• - Inadequate bone marrow reserve or organ function