Vanderbilt-Ingram Cancer Center

None Provided.

Criteria
 Inclusion Criteria:

 • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses

 • Aged at least 18 years. Patients from Japan aged at least 20 years.

 • Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).

 • Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib (with the exception of 1st line expansion cohort). In addition other lines of therapy may have been given.

 • Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib).

 • Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.

 • Male patients should be willing to use barrier contraception.

 • For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease.

 Exclusion Criteria:

 • Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment.

 • Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.

 • AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study).

 • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.

 • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.