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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 26, 2021 · 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: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Veliparib; Drug: Pemetrexed
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.
- 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.
- 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.
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.