Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/20/2019
Start Date:October 10, 2014
End Date:July 26, 2019

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A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus
carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung
Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell
lung cancer.


Inclusion Criteria:

- Subject must be ≥ 18 years of age. 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 CT scan as
defined by RECIST (version 1.1).

Exclusion Criteria:

- 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 EGFR mutation of exon 19 deletion or
L858R mutation in exon 21, or a known ALK gene rearrangement.

- Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
We found this trial at
24
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320 East North Avenue
Pittsburgh, Pennsylvania 15212
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6501 Truxtun Avenue
Bakersfield, California 93309
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Berazategui, Buenos Aires,
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400 Haddon Avenue
Camden, New Jersey 08103
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Camden, NJ
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
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Canton, OH
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Dallas, TX
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Detroit, Michigan 48202
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Detroit, MI
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Encinitas, California 92024
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Encinitas, CA
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Encinitas, California 92024
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Encinitas, CA
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1301 Central St
Evanston, Illinois 60201
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Evanston, IL
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3232 North Northhills Boulevard
Fayetteville, Arkansas 72703
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Fayetteville, AR
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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Goshen, IN
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3601 Cci Drive Northwest
Huntsville, Alabama 35805
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Huntsville, AL
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Lafayette, Louisiana 70503
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Lafayette, LA
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Lansing, MI
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Los Angeles, California 90017
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Los Angeles, CA
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Louisville, Kentucky 40202
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1707 Center Street
Mobile, Alabama 36604
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Mobile, AL
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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5501 Old York Road
Philadelphia, Pennsylvania 19141
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Philadelphia, PA
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San Antonio, Texas 78229
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San Antonio, TX
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Santa Rosa, California 95403
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Santa Rosa, CA
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Whittier, California 90603
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Whittier, CA
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