Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT02944396
Last Updated: 2019-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2016-12-23
2019-10-02
Brief Summary
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A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Veliparib and nivolumab with platinum doublet chemotherapy
Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
pemetrexed
intravenous; administered on Day 1 via infusion in a 21-day cycle
nivolumab
intravenous; administered on Day 1 via infusion in a 21-day cycle
paclitaxel
intravenous; administered on Day 1 via infusion in a 21-day cycle
veliparib
oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
carboplatin
intravenous; administered on Day 1 via infusion in a 21-day cycle
Veliparib with platinum doublet chemotherapy
Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
pemetrexed
intravenous; administered on Day 1 via infusion in a 21-day cycle
paclitaxel
intravenous; administered on Day 1 via infusion in a 21-day cycle
veliparib
oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
carboplatin
intravenous; administered on Day 1 via infusion in a 21-day cycle
Interventions
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pemetrexed
intravenous; administered on Day 1 via infusion in a 21-day cycle
nivolumab
intravenous; administered on Day 1 via infusion in a 21-day cycle
paclitaxel
intravenous; administered on Day 1 via infusion in a 21-day cycle
veliparib
oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
carboplatin
intravenous; administered on Day 1 via infusion in a 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC).
* Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resection or radiation or chemoradiation with curative intent at time of study screening.
* Participant must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
* Participant must have resolution to Grade 1 or lower of any toxic effects (excepting alopecia) of the most recent therapy prior to Cycle 1 Day 2.
* Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
* Participant must have adequate bone marrow, renal, and hepatic function.
Exclusion Criteria
* Participant has received prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
* Participant has received prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immunoregulatory receptors or mechanisms.
* Participant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.
* Participant has untreated central nervous system (CNS) metastases.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham - Main /ID# 155135
Birmingham, Alabama, United States
Icri /Id# 155593
Whittier, California, United States
Univ of Colorado Cancer Center /ID# 153820
Aurora, Colorado, United States
University of Chicago /ID# 153824
Chicago, Illinois, United States
Goshen Center for Cancer Care /ID# 153822
Goshen, Indiana, United States
Duke University Medical Center /ID# 153821
Durham, North Carolina, United States
Countries
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Other Identifiers
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2016-001658-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-534
Identifier Type: -
Identifier Source: org_study_id
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