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, intraconazole, EGFR sensitivity mutation
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 39
Healthy volunteers: no

Brief summary:
This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason

Detailed description:

Arms:
arm 1: Sequential treatments of AZD9291 alone followed by AZD9291+itraconazole, with a washout period in between.

Interventions: intervention 1: Pharmacokinetic sampling intervention 2: AZD9291 intervention 3: Itraconazole
Intervention descriptions: intervention 1: Blood samples taken pre and post dosing with AZD9291+/- itraconazole intervention 2: AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months. intervention 3: Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only

Protocol document: