Overview

This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatments veliparib, carboplatin, paclitaxel, cisplatin, pemetrexed
Phase phase 3
Target PARP
Sponsor AbbVie
Start date October 2014
End date November 2017
Trial size 525 participants
Trial identifier NCT02264990, 2014-002565-30, M14-359

Summary

This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in current or former smokers who are receiving their first cytotoxic therapy for metastatic or advanced non-squamous non-small cell lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
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
(Active Comparator)
Either carboplatin and paclitaxel, cisplatin and pemetrexed, or carboplatin and pemetrexed on Day 1 of a 21 day cycle.
carboplatin
Intravenous infusion
paclitaxel
Intravenous infusion
cisplatin
Intravenous infection
pemetrexed Alimta
Intravenous infusion

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 participants
time frame: Up to 5 years from first dose of study drug.
Progression Free Survival (PFS) in current smokers and all participants
time frame: Up to 5 years from first dose of study drug
Objective Response Rate (ORR) in current smokers and all participants
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: - Subject must be ≥ 18 years of age. Life expectancy > 12 weeks. - Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers. - Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening. - Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). Exclusion Criteria: - 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 squamous NSCLC, or an untreated known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement. - Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.

Additional Information

Official title A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.