Overview

This trial is active, not recruiting.

Condition squamous non-small cell lung cancer
Treatments veliparib, carboplatin, paclitaxel, placebo
Phase phase 3
Target PARP
Sponsor AbbVie
Start date April 2014
End date April 2017
Trial size 975 participants
Trial identifier NCT02106546, 2013-005020-42, M11-089

Summary

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.

United States Colorado
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
veliparib ABT-888
Oral Capsule
carboplatin
Intravenous infusion
paclitaxel
Intravenous infusion
(Placebo Comparator)
placebo on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
carboplatin
Intravenous infusion
paclitaxel
Intravenous infusion
placebo
Oral Capsule

Primary Outcomes

Measure
Overall Survival (OS) in current smokers
time frame: Up to 3 years from first dose of study drug

Secondary Outcomes

Measure
Overall Survival (OS) in all subjects
time frame: Up to 3 years from first dose of study drug
Progressive-Free Survival (PFS) in current smokers and in all subjects
time frame: Up to 3 years from first dose of study drug
Objective Response Rate (ORR) in current smokers and in all subjects
time frame: Up to 3 years from first dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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.

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.