Squamous Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase Ib/II Study of Docetaxel With or Without Buparlisib as Second Line Therapy for Patients With Advanced or Metastatic Squamous Non-small Cell Lung Cancer
This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized
double-blinded placebo controlled Phase II part.
The Phase Ib part will determine the Maximum Tolerated Dose (MTD)/Recommended Phase II Dose
(RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be
investigated in a Phase II randomized trial in patients with advanced or metastatic squamous
NSCLC.
Based on an overall review of safety and preliminary efficacy data done on 01-Dec-2014 showing marginal anti-tumor activity and newly emerged treatment options, a decision was taken to stop further development of this combination in patients with advanced or metastatic squamous NSCLC and Phase II of the study was not conducted. ;
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