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This is a single centre Phase 1 trial of the PI3K inhibitor BKM120, given concomitantly with palliative radiotherapy for the treatment of Non-Small Cell Lung Cancer (NSCLC).

A CR-UK phase I study of BKM120 in patients with non-small cell lung cancer (NSCLC) receiving thoracic radiotherapy.

To determine the safety, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of BKM120 when administered concomitantly with thoracic radiotherapy in patients with metastatic NSCLC.

Primary Objective

  • To determine the safety, dose-limiting toxicity (DLT) and MTD of BKM120 when administered concomitantly with thoracic radiotherapy in patients with incurable NSCLC

Secondary Objective

  • To investigate whether BKM120 alters tumour hypoxia and perfusion

Exploratory Objectives

  • To evaluate Akt phosphorylation as a predictive marker of response to BKM120
  • To investigate potential biomarkers that correlate with response to BKM120

Trial Publications

The primary results publication can be found here.