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.

• Register: EUCTR
• Last refreshed on: 10 August 2020
• Main ID: EUCTR2014-002565-30-DE
• Date of registration: 10/11/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 16/01/2015
• Target sample size: 595
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002565-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; 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

Argentina, Australia, Canada, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

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).
- Subject must consent to provide archived tissue or cytology sample of NSCLD 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

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 EGFR mutation (exon 19 deletion or L858R mutation in exon 21) or ALK gene rearrangement. Subjects' EGFR mutation or ALK gene rearrangement according to local standard of care status must be known prior to study entry.
- Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.


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

Health Condition(s) or Problem(s) studied

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

Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer (NSCLC)
MedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864

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 (ABT-888)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Product Name: Carboplatin
Product Code: Carboplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CARBOPLATIN
CAS Number: 41575-94-4
Other descriptive name: CARBOPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: Paclitaxel
Product Code: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

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.

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 LSP + subgroup.

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.

Secondary Outcome(s)

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).

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.

Secondary ID(s)

2014-002565-30-FI

M14-359

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 16/01/2015
Contact: