Conditions: Advanced Non Small Cell Lung Cancer Advanced (Inoperable) Non Small Cell Lung Cancer
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, EGFR sensitivity mutation, food effect
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 38
Healthy volunteers: no

Brief summary:
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection.

Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal \[fed\], and once in the fasted state \[fasted\]), with a washout period of 9 days between doses.

Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 \[TP 2\] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients

Detailed description:

Arms:
arm 1: AZD9291 tablets following a period of fasting arm 2: AZD9291 tablets following a high-fat meal.

Interventions: intervention 1: AZD9291 tablets intervention 2: Pharmacokinetic sampling - AZD9291 intervention 3: Dietary Fasted intervention 4: Dietary High Fat intervention 5: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months. intervention 2: Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal. intervention 3: Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing intervention 4: Allocated breakfast prior to dosing with 80mg AZD9291 tablet intervention 5: Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.

Protocol document: