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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02106546
Registration number
NCT02106546
Ethics application status
Date submitted
4/04/2014
Date registered
8/04/2014
Titles & IDs
Public title
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
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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)
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Secondary ID [1]
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2013-005020-42
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Secondary ID [2]
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M11-089
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Veliparib
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Placebo to veliparib
Experimental: Veliparib + Carboplatin + Paclitaxel - Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
Placebo comparator: Placebo + Carboplatin + Paclitaxel - Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
Treatment: Drugs: Carboplatin
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
Treatment: Drugs: Veliparib
Capsules taken orally twice a day, 12 hours apart.
Treatment: Drugs: Paclitaxel
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Treatment: Drugs: Placebo to veliparib
Capsules taken orally twice a day, 12 hours apart.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in current smokers
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 3 years from first dose of study drug
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Secondary outcome [1]
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Overall Survival (OS) in all subjects
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 3 years from first dose of study drug
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Secondary outcome [2]
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Progressive-Free Survival (PFS) in current smokers and in all subjects
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 3 years from first dose of study drug
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Secondary outcome [3]
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Objective Response Rate (ORR) in current smokers and in all subjects
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Assessment method [3]
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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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Timepoint [3]
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Up to 3 years from first dose of study drug
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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).
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Minimum age
18
Years
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/04/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/11/2019
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Sample size
Target
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Accrual to date
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Final
970
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Southern Medical Day Care Ctr /ID# 125604 - Wollongong
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Sunshine Coast University Hosp /ID# 125608 - Birtinya
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The Townsville Hospital /ID# 125609 - Douglas
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Flinders Centre for Innovation /ID# 125605 - Bedford Park
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The Queen Elizabeth Hospital /ID# 125607 - Woodville
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Barwon Health University Hospital Geelong /ID# 125606 - Geelong
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2500 - Wollongong
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4575 - Birtinya
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4814 - Douglas
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5042 - Bedford Park
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5011 - Woodville
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3220 - Geelong
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Wirral
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Funding & Sponsors
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Name
AbbVie
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Summary
Brief summary
The purpose of this study is 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 adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).
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Trial website
https://clinicaltrials.gov/study/NCT02106546
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Trial related presentations / publications
Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. doi: 10.1200/JCO.20.03318. Epub 2021 Aug 26.
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Public notes
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Contacts
Principal investigator
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AbbVie Inc.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02106546