Randomized, Double-Blind, Multicenter, Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/20/2019
Start Date:April 10, 2014
End Date:July 15, 2019

Use our guide to learn which trials are right for you!

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of
veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and
paclitaxel in subjects with advanced or metastatic squamous NSCLC.


Inclusion Criteria:

1. Life expectancy > 12 weeks

2. Subject must have cytologically or histologically confirmed squamous NSCLC.

3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to
surgical resection or radiation with curative intent at time of study Screening.

4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable
to surgical resection or radiation with curative intent are eligible.

5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a Computerized
Tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors
(RECIST - version 1.1).

Exclusion Criteria:

1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).

2. Subject has a known hypersensitivity to platinum compounds.

3. Subject has peripheral neuropathy >= grade 2.

4. Subject has non-squamous NSCLC, or a 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.

5. Subject has received prior cytotoxic chemotherapy (including definitive
chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
We found this trial at
40
sites
1 Medical Center Drive
Lebanon, New Hampshire 03766
2514
mi
from 91732
Lebanon, NH
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from 91732
Arlington Heights, IL
Click here to add this to my saved trials
Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
?
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
1210
mi
from 91732
Austin, TX
Click here to add this to my saved trials
4101 James Casey Street
Austin, Texas 78745
1211
mi
from 91732
Austin, TX
Click here to add this to my saved trials
?
mi
from 91732
Boise, ID
Click here to add this to my saved trials
?
mi
from 91732
Burlington, VT
Click here to add this to my saved trials
4875 Higbee Avenue Northwest
Canton, Ohio 44718
2044
mi
from 91732
Canton, OH
Click here to add this to my saved trials
?
mi
from 91732
Coon Rapids, MN
Click here to add this to my saved trials
?
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1221
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
?
mi
from 91732
Evanston, IL
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
2315
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Gainesville, Florida 32608
2104
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
7710 Wolf River Circle
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
?
mi
from 91732
Goshen, IN
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from 91732
Hackensack, NJ
Click here to add this to my saved trials
1 Ingalls Drive
Harvey, Illinois 60426
1725
mi
from 91732
Harvey, IL
Click here to add this to my saved trials
200 Medical Center Drive
Hazard, Kentucky 41701
1953
mi
from 91732
Hazard, KY
Click here to add this to my saved trials
500 University Drive
Hershey, Pennsylvania 17033
2294
mi
from 91732
Hershey, PA
Click here to add this to my saved trials
?
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46237
?
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
7015 A C Skinner Parkway
Jacksonville, Florida 32256
2135
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
?
mi
from 91732
Jonesboro, AR
Click here to add this to my saved trials
Lansing, Michigan 48912
?
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
?
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
4004 Pioneer Woods Drive
Lincoln, Nebraska 68506
1257
mi
from 91732
Lincoln, NE
Click here to add this to my saved trials
Lincoln, Nebraska 68510
?
mi
from 91732
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90017
?
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
910 East 26th Street
Minneapolis, Minnesota 55404
1509
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
3550 Northeast Loop 286
Paris, Texas 75460
1288
mi
from 91732
Paris, TX
Click here to add this to my saved trials
?
mi
from 91732
Portland, OR
Click here to add this to my saved trials
2501 Northeast 134th Street
Vancouver, Washington 98684
840
mi
from 91732
Vancouver, WA
Click here to add this to my saved trials
1700 West Highway 6
Waco, Texas 76712
1218
mi
from 91732
Waco, TX
Click here to add this to my saved trials
West Bloomfield, Michigan 48322
?
mi
from 91732
West Bloomfield, MI
Click here to add this to my saved trials
Wollongong, New South Wales
?
mi
from 91732
Wollongong,
Click here to add this to my saved trials
?
mi
from 91732
Zion, IL
Click here to add this to my saved trials