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

Completed · Phase 3 · Has a placebo group

Conditions studied: Squamous Non-Small Cell Lung Cancer

In brief

The purpose of this study is 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 adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT02106546

Run by

AbbVie

People needed

970

Starts

2014-04-10

Expected to finish

2019-11-20

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Life expectancy > 12 weeks
• Subject must have cytologically or histologically confirmed squamous NSCLC.
• 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.
• Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
• 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).

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 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.
• Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Where it is running

• LA Hem-Oncology Med Group /ID# 129178 — Los Angeles, California, United States
• VA Eastern Colorado Healthcare System /ID# 128065 — Aurora, Colorado, United States
• Holy Cross Hospital /ID# 128074 — Fort Lauderdale, Florida, United States
• University of Florida - Archer /ID# 126476 — Gainesville, Florida, United States
• Cancer Specialists of North Florida - Southpoint /ID# 127815 — Jacksonville, Florida, United States
• Winship Cancer Institute of Emory University /ID# 124061 — Atlanta, Georgia, United States
• St. Luke's Mountain States Tumor Institute - Boise /ID# 124059 — Boise, Idaho, United States
• Illinois Cancer Specialists /ID# 127468 — Arlington Heights, Illinois, United States
• NorthShore University HealthSystem - Evanston Hospital /ID# 128585 — Evanston, Illinois, United States
• Ingalls Memorial Hosp /ID# 128360 — Harvey, Illinois, United States
• Midwestern Regional CTC /ID# 126124 — Zion, Illinois, United States
• Goshen Center for Cancer Care /ID# 123875 — Goshen, Indiana, United States
• Franciscan St. Francis Health /ID# 126678 — Indianapolis, Indiana, United States
• Appalachian Regional Healthcare, Inc (ARH) /ID# 128061 — Hazard, Kentucky, United States
• Henry Ford Health System /ID# 126500 — Detroit, Michigan, United States
• Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156 — Lansing, Michigan, United States
• Minnesota Oncology Hematology, PA /ID# 127473 — Minneapolis, Minnesota, United States
• Nebraska Hematology Oncology /ID# 127699 — Lincoln, Nebraska, United States
• SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477 — Lincoln, Nebraska, United States
• Comprehensive Cancer Ctrs Neva /ID# 127491 — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center /ID# 128075 — Lebanon, New Hampshire, United States
• Hackensack Univ Med Ctr /ID# 124057 — Hackensack, New Jersey, United States
• Gabrail Cancer Center Research /ID# 127415 — Canton, Ohio, United States
• Penn State University and Milton S. Hershey Medical Center /ID# 126676 — Hershey, Pennsylvania, United States
• Northeast Arkansas Clinical Ch /ID# 128071 — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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