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
  • Lung Cancer - Non-Small Cell Lung Cancer (NSCLC)
  • Study Drug
  • Paclitaxel
  • Placebo for Veliparib
  • Carboplatin
  • Veliparib
  • 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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