The purpose of this study is 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 adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
970
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
Capsules taken orally twice a day, 12 hours apart.
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Overall Survival (OS) in current smokers
Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
Time frame: Up to 3 years from first dose of study drug
Overall Survival (OS) in all subjects
Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
Time frame: Up to 3 years from first dose of study drug
Progressive-Free Survival (PFS) in current smokers and in all subjects
Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.
Time frame: Up to 3 years from first dose of study drug
Objective Response Rate (ORR) in current smokers and in all subjects
Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)
Time frame: Up to 3 years from first dose of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Capsules taken orally twice a day, 12 hours apart.
Northeast Arkansas Clinical Ch /ID# 128071
Jonesboro, Arkansas, United States
LA Hem-Oncology Med Group /ID# 129178
Los Angeles, California, United States
VA Eastern Colorado Healthcare System /ID# 128065
Aurora, Colorado, United States
Holy Cross Hospital /ID# 128074
Fort Lauderdale, Florida, United States
University of Florida - Archer /ID# 126476
Gainesville, Florida, United States
Cancer Specialists of North Florida - Southpoint /ID# 127815
Jacksonville, Florida, United States
Winship Cancer Institute of Emory University /ID# 124061
Atlanta, Georgia, United States
St. Luke's Mountain States Tumor Institute - Boise /ID# 124059
Boise, Idaho, United States
Illinois Cancer Specialists /ID# 127468
Arlington Heights, Illinois, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 128585
Evanston, Illinois, United States
...and 215 more locations