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

Completed · Phase 3

Conditions studied: Non-squamous Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02264990

Run by

AbbVie

People needed

595

Starts

2014-09-30

Expected to finish

2020-02-21

Last updated by the study team

2021-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Alabama /ID# 131518 — Mobile, Alabama, United States
• Highlands Oncology Group /ID# 131250 — Springdale, Arkansas, United States
• CBCC Global Research, Inc. at /ID# 132709 — Bakersfield, California, United States
• California Cancer Assoc. R&E /ID# 131392 — Encinitas, California, United States
• California Cancer Assoc. R&E /ID# 131949 — Encinitas, California, United States
• LA Hem-Oncology Med Group /ID# 131639 — Los Angeles, California, United States
• St Jude Hospital dba St Joseph /ID# 132943 — Santa Rosa, California, United States
• Icri /Id# 132942 — Whittier, California, United States
• University of Florida - Archer /ID# 132408 — Gainesville, Florida, United States
• NorthShore University HealthSystem - Evanston Hospital /ID# 130200 — Evanston, Illinois, United States
• Goshen Center for Cancer Care /ID# 130216 — Goshen, Indiana, United States
• University of Louisville /ID# 130217 — Louisville, Kentucky, United States
• Cancer Center of Acadiana /ID# 133611 — Lafayette, Louisiana, United States
• Henry Ford Health System /ID# 130234 — Detroit, Michigan, United States
• Herbert Herman Cancer Center /ID# 130239 — Lansing, Michigan, United States
• Washington University-School of Medicine /ID# 131651 — St Louis, Missouri, United States
• MD Anderson Cancer Center at Cooper - Camden /ID# 131490 — Camden, New Jersey, United States
• Gabrail Cancer Center Research /ID# 130205 — Canton, Ohio, United States
• Univ Oklahoma HSC /ID# 132888 — Oklahoma City, Oklahoma, United States
• Albert Einstein Medical Center /ID# 134498 — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital /ID# 134049 — Pittsburgh, Pennsylvania, United States
• The Jones Clinic, PC /ID# 130215 — Germantown, Tennessee, United States
• UT Southwestern Medical Center /ID# 130236 — Dallas, Texas, United States
• Univ Texas HSC San Antonio /ID# 132972 — San Antonio, Texas, United States
• Clearview Cancer Institute /ID# 131434 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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