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
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 17, 2020 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- AbbVie
- Interventions being studied
- Drug: Carboplatin; Drug: Veliparib; Drug: Paclitaxel; Drug: Placebo to veliparib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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).
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Northeast Arkansas Clinical Ch /ID# 128071Jonesboro, Arkansas
- LA Hem-Oncology Med Group /ID# 129178Los Angeles, California
- VA Eastern Colorado Healthcare System /ID# 128065Aurora, Colorado
- Holy Cross Hospital /ID# 128074Fort Lauderdale, Florida
- University of Florida - Archer /ID# 126476Gainesville, Florida
- Cancer Specialists of North Florida - Southpoint /ID# 127815Jacksonville, Florida
- Winship Cancer Institute of Emory University /ID# 124061Atlanta, Georgia
- St. Luke's Mountain States Tumor Institute - Boise /ID# 124059Boise, Idaho
- Illinois Cancer Specialists /ID# 127468Arlington Heights, Illinois
- NorthShore University HealthSystem - Evanston Hospital /ID# 128585Evanston, Illinois
- Ingalls Memorial Hosp /ID# 128360Harvey, Illinois
- Midwestern Regional CTC /ID# 126124Zion, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2020. Always confirm current availability with the study team.