NCT02106546

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 970 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
DRUG	Veliparib	Capsules taken orally twice a day, 12 hours apart.
DRUG	Paclitaxel	Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
DRUG	Placebo to veliparib	Capsules taken orally twice a day, 12 hours apart.

Timeline

• Start date: 2014-04-10
• Primary completion: 2017-01-03
• Completion: 2019-11-20
• First posted: 2014-04-08
• Last updated: 2020-11-17

Locations

225 sites across 38 countries: United States, Australia, Austria, Belarus, Brazil, Canada, Croatia, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study