Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 2/20/2019 |
Start Date: | October 10, 2014 |
End Date: | July 26, 2019 |
A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus
carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung
Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell
lung cancer.
carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung
Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell
lung cancer.
Inclusion Criteria:
- Subject must be ≥ 18 years of age. 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 CT scan as
defined by 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 EGFR mutation of exon 19 deletion or
L858R mutation in exon 21, or a known ALK gene rearrangement.
- Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
We found this trial at
24
sites
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