Non-Small Cell Lunch Cancer Clinical Trial
Official title:
A Dose-finding Phase Ib Study Followed by a Randomized, Double-blind Phase II Study of Carboplatin and Paclitaxel With or Without Buparlisib in Patients With Previously Untreated Metastatic Non-small Cell Lung Cancer (NSCLC) of Squamous Histology
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.
Based on the observation of DLTs and AEs, the safety profile of this investigational treatment was considered challenging requiring dose reductions/interruptions and even the evaluation of an alternative schedule of buparlisib administration. The study was early terminated, and the primary objective was not met. Therefore the phase ll portion of the study was never initiated. ;