This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of
epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer
(NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase
inhibitor (TKI) agent.
Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of
fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.
Continuous Access will allow patients further access to osimertinib after the PK phase (Part
A). All patients from Part A who completed treatment may continue to receive osimertinib 80
mg once daily until: they are no longer deriving clinical benefit; or any other reason.