A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics
and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small
Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor
Receptor Tyrosine Kinase Inhibitor Agent
Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291
and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291
administered orally once daily in Chinese patients with locally advanced or metastatic non
small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent.
2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given
orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed
following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment
of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response
Evaluation Criteria in Solid Tumours (RECIST) version 1.1.