Randomized, Open-Label, Multicenter 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 Who Are Current or Former Smokers.
- Conditions
- Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002565-30-HU
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 595
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects with metastatic or advanced NSCLC.;Secondary Objective: The secondary objectives of the study are to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in the entire study population ; to compare progression-free survival (PFS) and to compare objective response rate (ORR) between the two treatment arms in LSP positive subjects or in entire study population.;Primary end point(s): Overall Survival (OS) in LSP + subgroup.;Timepoint(s) of evaluation of this end point: Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression Free Survival (PFS) in LSP+ subgroup, Objective Response Rate (ORR) in LSP+ subgroup, OS in all subjects, PFS in all subjects,ORR in all subjects. ;Timepoint(s) of evaluation of this end point: PFS will be defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached. ORR is defined as the proportion of subjects with complete or partial response using measurements according to RECIST (version 1.1).