2.1 Primary~• The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib and BKM120 will be determined.~2.2 Secondary~The pharmacokinetic (PK) profile of gefitinib in combination with BKM120 will be determined.~The preliminary anti-tumor activity of gefitinib in combination with BKM120 will be determined.~The pharmacodynamic target modulation effects using a hair follicle assay will be determined.~2.3 Exploratory~The role of circulating tumour cells as assessed by a microfluidic device will be analyzed and the genetic alterations implicated in lung cancer, including but not limited to EGFR mutations, PI3KCA mutations, PTEN loss will be characterized.~The feasibility of detecting somatic mutations from plasma DNA will be ascertained.
The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib and BKM120 will be determined.