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 C

• Status: Completed
• Trial end date: 2020-02-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel; Pemetrexed; Veliparib

Criteria

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.