Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Identifier
M15-534
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Lung Cancer - Non-Small Cell Lung Cancer (NSCLC)
  • Study Drug
  • pemetrexed
  • nivolumab
  • paclitaxel
  • veliparib
  • carboplatin
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (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
    University of Alabama at Birmingham - Main /ID# 155135
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Icri /Id# 155593
    Whittier, California, United States, 90603
    Status
    Not applicable
    Location
    Univ of Colorado Cancer Center /ID# 153820
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    University of Chicago /ID# 153824
    Chicago, Illinois, United States, 60637-1443
    Status
    Not applicable
    Location
    Goshen Center for Cancer Care /ID# 153822
    Goshen, Indiana, United States, 46526
    Status
    Not applicable
    Location
    Duke University Medical Center /ID# 153821
    Durham, North Carolina, United States, 27710-3000
    Status
    Not applicable