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

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 595 人开始时间: 2014年12月9日最近更新: 2020年4月6日

试验速览

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•- 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).
•-Subject must consent to provide archived tissue or cytology sample of NSCLC lesion (primary or metastatic) for analysis if available
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 286
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 309

•- 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.

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