CompletedPhase 3NCT02264990

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

Checked against the public recordLast updated Feb 26, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations140
SponsorAbbVie
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AbbVie
Interventions being studied
Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Veliparib; Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Subject must be ≥ 18 years of age with 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 computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (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 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 or chemoradiotherapy for NSCLC.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Clearview Cancer Institute /ID# 131434Huntsville, Alabama
  • University of South Alabama /ID# 131518Mobile, Alabama
  • Highlands Oncology Group /ID# 131250Springdale, Arkansas
  • CBCC Global Research, Inc. at /ID# 132709Bakersfield, California
  • California Cancer Assoc. R&E /ID# 131392Encinitas, California
  • California Cancer Assoc. R&E /ID# 131949Encinitas, California
  • LA Hem-Oncology Med Group /ID# 131639Los Angeles, California
  • St Jude Hospital dba St Joseph /ID# 132943Santa Rosa, California
  • Icri /Id# 132942Whittier, California
  • University of Florida - Archer /ID# 132408Gainesville, Florida
  • NorthShore University HealthSystem - Evanston Hospital /ID# 130200Evanston, Illinois
  • Goshen Center for Cancer Care /ID# 130216Goshen, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 26, 2021. Always confirm current availability with the study team.

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