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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02264990




Registration number
NCT02264990
Ethics application status
Date submitted
9/10/2014
Date registered
15/10/2014

Titles & IDs
Public title
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and 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
Secondary ID [1] 0 0
2014-002565-30
Secondary ID [2] 0 0
M14-359
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-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
Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Veliparib
Treatment: Drugs - Pemetrexed

Experimental: Veliparib + Carboplatin + Paclitaxel - Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Active comparator: Investigator's Choice Chemotherapy - Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.


Treatment: Drugs: Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle

Treatment: Drugs: Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle

Treatment: Drugs: Cisplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle

Treatment: Drugs: Veliparib
Oral capsule, administered twice daily for 7 days in each 21-day cycle

Treatment: Drugs: Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
Timepoint [1] 0 0
From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Secondary outcome [1] 0 0
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
Timepoint [1] 0 0
From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Secondary outcome [2] 0 0
Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
Timepoint [2] 0 0
Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.
Secondary outcome [3] 0 0
Overall Survival in All Participants
Timepoint [3] 0 0
From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Secondary outcome [4] 0 0
Progression Free Survival (PFS) in All Participants
Timepoint [4] 0 0
From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Secondary outcome [5] 0 0
Objective Response Rate (ORR) in All Participants
Timepoint [5] 0 0
Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.

Eligibility
Key inclusion criteria
* Subject must be = 18 years of age with 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 computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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.
* Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.

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
Open (masking not used)
Who is / are masked / blinded?



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
30/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2020
Sample size
Target
Accrual to date
Final
595
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
Recruitment hospital [1] 0 0
St George Hospital /ID# 132481 - Kogarah
Recruitment hospital [2] 0 0
Southern Medical Day Care Ctr /ID# 132482 - Wollongong
Recruitment hospital [3] 0 0
Flinders Centre for Innovation /ID# 134288 - Bedford Park
Recruitment hospital [4] 0 0
Royal Hobart Hospital /ID# 132477 - Hobart
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Illinois
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Indiana
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Kentucky
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Louisiana
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Michigan
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Missouri
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New Jersey
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Argentina
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Berazategui, Buenos Aires
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Argentina
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Pergamino
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Argentina
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Rosario, Santa FE
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
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Ontario
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Canada
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Quebec
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Czechia
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Liberec
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Czechia
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Ostrava
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Czechia
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Pardubice
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Czechia
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Prague
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Denmark
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Syddanmark
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Finland
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Pori
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Finland
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Vaasa
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Germany
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Berlin
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Germany
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Grosshansdorf
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Germany
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Hamburg
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Germany
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Löwenstein
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Budapest
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Debrecen
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Edelény
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Farkasgyepu
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Gyor
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Kékesteto
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Israel
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Be'er Ya'akov
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Japan
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Aichi
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Japan
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Fukuoka
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Hokkaido
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Kanagawa
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Miyagi
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Osaka
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Tokyo
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Yamaguchi
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Hiroshima
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Kishiwada
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Busan Gwang Yeogsi
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Gyeonggido
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Incheon Gwang Yeogsi
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Jeonranamdo
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Seoul Teugbyeolsi
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Cheongju
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Netherlands
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Amsterdam
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Eindhoven
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Harderwijk
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Nieuwegein
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S Hertogenbosch
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New Zealand
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Christchurch
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New Zealand
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Wellington
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Russian Federation
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Moskva
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Russian Federation
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Sverdlovskaya Oblast
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Orenburg
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Sankt-Peterburg
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Saransk
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St. Petersburg
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Gauteng
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Alcorcon
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Alicante
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Spain
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Valencia
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Taiwan
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Taichung
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Taiwan
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Dalin Township
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Taipei City
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Turkey
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Ankara
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Bursa
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Gaziantep
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Izmir
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Turkey
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Malatya
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United Kingdom
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England
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United Kingdom
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Gloucestershire
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United Kingdom
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Norfolk
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Bath
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Blackburn
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United Kingdom
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Colchester
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United Kingdom
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Cottingham
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United Kingdom
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Doncaster
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United Kingdom
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Great Yarmouth
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United Kingdom
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Gwent
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United Kingdom
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Huddersfield
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United Kingdom
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London
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United Kingdom
State/province [112] 0 0
Newcastle Upon Tyne
Country [113] 0 0
United Kingdom
State/province [113] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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), Analytic code
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.
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.
Available for what types of analyses?
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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02264990