Randomized, Double-Blind, Multicenter, Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005020-42-SK

Enrollment

975

Registered

2014-03-24

Start date

2014-05-15

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC) MedDRA version: 18.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864

Interventions

Product Name: Veliparib 40 mg Product Code: ABT-888 Pharmaceutical Form: Capsule INN or Proposed INN: Veliparib Current Sponsor code: AB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Subject must be = 18 years of age. -Life expectancy > 12 weeks -Subject must have cytologically or histologically confirmed squamous NSCLC. -Subject must have advanced or metastatic squamous NSCLC (stage IIIB or IV) that is not amenable to surgical resection or radiation with curative intent at time of study Screening. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible. -Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). 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 325 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 650

Exclusion criteria

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 non-squamous NSCLC, or a 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 (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objectives of the study are to assess the effects of veliparib combination therapy on OS in all subjects, progression-free survival (PFS), and objective response rate (ORR) in current smokers and in all subjects.;Primary end point(s): Overall Survival (OS) in current smokers.;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. ;Main Objective: The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in subjects with previously untreated locally advanced and metastatic squamous NSCLC	—

Measure

Time frame

Secondary Objective: The secondary objectives of the study are to assess the effects of veliparib combination therapy on OS in all subjects, progression-free survival (PFS), and objective response rate (ORR) in current smokers and in all subjects.;Primary end point(s): Overall Survival (OS) in current smokers.;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. ;Main Objective: The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in subjects with previously untreated locally advanced and metastatic squamous NSCLC

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Secondary

Measure	Time frame
Secondary end point(s): OS in whole population, Progression-free Survival (PFS); Objective Response Rate (ORR).; Timepoint(s) of evaluation of this end point: OS: see E.5.1.1. PFS will be defined as the number of days from the date of randomization to the date of disease progression or death if disease progression is not reached. Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1).	—

Measure

Time frame

Secondary end point(s): OS in whole population, Progression-free Survival (PFS); Objective Response Rate (ORR).; Timepoint(s) of evaluation of this end point: OS: see E.5.1.1. PFS will be defined as the number of days from the date of randomization to the date of disease progression or death if disease progression is not reached. Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1).

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Countries

Australia, Austria, Belarus, Brazil, Canada, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

Abbvie Limited

eu-clinical-trials@abbvie.com+44 1628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026