Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer
Status:
Terminated
Trial end date:
2014-06-18
Target enrollment:
Participant gender:
Summary
The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended
Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week
carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC.
The purpose of the Phase II portion of the study was to assess the treatment effect of adding
buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel
on progression free survival (PFS) in patients with previously untreated metastatic squamous
NSCLC.