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Brief Title A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects With Stage III Non-Small Cell Lung Cancer
Official Title A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects With Stage III Non-Small Cell Lung Cancer (NSCLC)
Principal Investigator Vokes, Everett
Brief Summary This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy (Phase 1 portion) and to assess whether the addition of oral veliparib versus placebo to Paclitaxel/Carboplatin-based chemoradiotherapy with Paclitaxel/Carboplatin consolidation will improve progression-free survival (PFS) in subjects with Stage III non-small cell lung cancer (Phase 2 portion).
Gender Both
Ages 18 Years
Enrollment 174
Accepts Healthy Volunteers No
Lead Sponsor AbbVieIndustry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name Site Reference ID/Investigator# 133037, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Non-small Cell Lung Cancer Stage III
Detail for Health Professional (on clinicaltrials.gov)
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