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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02106546




Registration number
NCT02106546
Ethics application status
Date submitted
4/04/2014
Date registered
8/04/2014
Date last updated
20/02/2020

Titles & IDs
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
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)
Secondary ID [1] 0 0
2013-005020-42
Secondary ID [2] 0 0
M11-089
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - carboplatin
Treatment: Drugs - veliparib
Treatment: Drugs - paclitaxel
Treatment: Drugs - placebo

Experimental: veliparib and carboplatin and paclitaxel - veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle

Placebo Comparator: placebo and carboplatin and paclitaxel - placebo on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle


Treatment: Drugs: carboplatin
Intravenous infusion

Treatment: Drugs: veliparib
Oral Capsule

Treatment: Drugs: paclitaxel
Intravenous infusion

Treatment: Drugs: placebo
Oral Capsule

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in current smokers - 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.
Timepoint [1] 0 0
Up to 3 years from first dose of study drug
Secondary outcome [1] 0 0
Overall Survival (OS) in all subjects - 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.
Timepoint [1] 0 0
Up to 3 years from first dose of study drug
Secondary outcome [2] 0 0
Progressive-Free Survival (PFS) in current smokers and in all subjects - 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.
Timepoint [2] 0 0
Up to 3 years from first dose of study drug
Secondary outcome [3] 0 0
Objective Response Rate (ORR) in current smokers and in all subjects - 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)
Timepoint [3] 0 0
Up to 3 years from first dose of study drug

Eligibility
Key inclusion criteria
1. Life expectancy > 12 weeks

2. Subject must have cytologically or histologically confirmed squamous NSCLC.

3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to
surgical resection or radiation with curative intent at time of study Screening.

4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable
to surgical resection or radiation with curative intent are eligible.

5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a Computerized
Tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors
(RECIST - version 1.1).
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).

2. Subject has a known hypersensitivity to platinum compounds.

3. Subject has peripheral neuropathy >= grade 2.

4. Subject has non-squamous NSCLC, or a known Epidermal Growth Factor Receptor (EGFR)
mutation of exon 19 deletion or L858R mutation in exon 21, or a known Anaplastic
Lymphoma Kinase (ALK) gene rearrangement.

5. Subject has received prior cytotoxic chemotherapy (including definitive
chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Southern Medical Day Care Ctr /ID# 125604 - Wollongong
Recruitment hospital [2] 0 0
Sunshine Coast University Hosp /ID# 125608 - Birtinya
Recruitment hospital [3] 0 0
The Townsville Hospital /ID# 125609 - Douglas
Recruitment hospital [4] 0 0
Flinders Centre for Innovation /ID# 125605 - Bedford Park
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital /ID# 125607 - Woodville
Recruitment hospital [6] 0 0
Barwon Health University Hospital Geelong /ID# 125606 - Geelong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
5011 - Woodville
Recruitment postcode(s) [6] 0 0
3220 - Geelong
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of
veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and
paclitaxel in subjects with advanced or metastatic squamous NSCLC.
Trial website
https://clinicaltrials.gov/show/NCT02106546
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications