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)

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2013-005020-42-SK
• Date of registration: 24/03/2014
• Prospective Registration: Yes
• Primary sponsor: Abbvie Deutschland GmbH & Co. KG
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 15/05/2014
• Target sample size: 975
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005020-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbvie Limited

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbvie Limited

Key inclusion & exclusion 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:
-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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Veliparib 40 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: VELIPARIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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.

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.

Primary end point(s): Overall Survival (OS) in current smokers.

Secondary Outcome(s)

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).

Secondary end point(s): OS in whole population, Progression-free Survival (PFS); Objective Response Rate (ORR).

Secondary ID(s)

M11-089

Source(s) of Monetary Support

Abbvie Inc.

Ethics review

Status: Approved
Approval date: 01/04/2014
Contact: