A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC)
Study Identifier
M14-360
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Results Available
Protocol and Statistical Analysis Plan
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 1/Phase 2
Sex
Female & Male
Age
18+ years
Protocol Summary
This study seeks to establish
- the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent paclitaxel/carboplatin-based chemoradiotherapy (CRT) and consolidation with paclitaxel/carboplatin-based chemotherapy (Phase 1 portion), and
- to assess whether the addition of oral veliparib versus placebo to paclitaxel/carboplatin-based chemoradiotherapy with paclitaxel/carboplatin consolidation will improve progression-free survival (PFS) in adults with Stage III non-small cell lung cancer (Phase 2 portion).
A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
Study Locations
Location
Status
Location
Ucsd /Id# 133037
La Jolla, California, United States, 92093
Status
Not applicable
Location
Christiana Care Health Service /ID# 133486
Newark, Delaware, United States, 19713
Status
Not applicable
Location
University of Chicago /ID# 133828
Chicago, Illinois, United States, 60637-1443
Status
Not applicable
Location
Univ Maryland School Medicine /ID# 132944
Baltimore, Maryland, United States, 21201
Status
Not applicable
Location
Dana-Farber Cancer Institute /ID# 133494
Boston, Massachusetts, United States, 02215
Status
Not applicable
Location
SUNY Upstate Medical University - Downtown /ID# 133492
Syracuse, New York, United States, 13210
Status
Not applicable
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