Status:
COMPLETED
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Lead Sponsor:
AbbVie
Conditions:
Non-squamous Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or adv...
Eligibility Criteria
Inclusion
- Subject must be ≥ 18 years of age with life expectancy \> 12 weeks.
- Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
- Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
- Subject 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.
Exclusion
- Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
- Subject has a known hypersensitivity to platinum compounds.
- Subject has peripheral neuropathy ≥ grade 2.
- Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
- Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2020
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT02264990
Start Date
September 30 2014
End Date
February 21 2020
Last Update
February 26 2021
Active Locations (140)
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1
Clearview Cancer Institute /ID# 131434
Huntsville, Alabama, United States, 35805
2
University of South Alabama /ID# 131518
Mobile, Alabama, United States, 36617
3
Highlands Oncology Group /ID# 131250
Springdale, Arkansas, United States, 72762
4
CBCC Global Research, Inc. at /ID# 132709
Bakersfield, California, United States, 93309