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
- Conditions
- Squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02106546
- Lead Sponsor
- AbbVie
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 970
- Life expectancy > 12 weeks
- Subject must have cytologically or histologically confirmed squamous NSCLC.
- 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.
- Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
- 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).
- 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 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.
- Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Carboplatin + Paclitaxel Placebo to veliparib Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression. Veliparib + Carboplatin + Paclitaxel Carboplatin Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression. Veliparib + Carboplatin + Paclitaxel Veliparib Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression. Veliparib + Carboplatin + Paclitaxel Paclitaxel Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression. Placebo + Carboplatin + Paclitaxel Carboplatin Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression. Placebo + Carboplatin + Paclitaxel Paclitaxel Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) in current smokers Up to 3 years from first dose of study drug 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.
- Secondary Outcome Measures
Name Time Method Progressive-Free Survival (PFS) in current smokers and in all subjects Up to 3 years from first dose of study drug 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.
Objective Response Rate (ORR) in current smokers and in all subjects Up to 3 years from first dose of study drug 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)
Overall Survival (OS) in all subjects Up to 3 years from first dose of study drug 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.
Trial Locations
- Locations (225)
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
Scroll for more (215 remaining)Northeast Arkansas Clinical Ch /ID# 128071🇺🇸Jonesboro, Arkansas, United States