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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02264990
Registration number
NCT02264990
Ethics application status
Date submitted
9/10/2014
Date registered
15/10/2014
Date last updated
26/02/2021
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
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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
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Secondary ID [1]
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2014-002565-30
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Secondary ID [2]
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M14-359
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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:
Non-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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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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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 the Lung Subtype Panel Positive Subgroup
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Assessment method [1]
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Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
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Assessment method [1]
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Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
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Assessment method [2]
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Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
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Timepoint [2]
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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.
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Secondary outcome [3]
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Overall Survival in All Participants
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Assessment method [3]
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Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Progression Free Survival (PFS) in All Participants
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Assessment method [4]
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Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
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Timepoint [4]
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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.
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Secondary outcome [5]
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Objective Response Rate (ORR) in All Participants
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Assessment method [5]
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Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
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Timepoint [5]
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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.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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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
- 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.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
30/09/2014
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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
21/02/2020
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Sample size
Target
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Accrual to date
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Final
595
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
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Recruitment hospital [1]
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St George Hospital /ID# 132481 - Kogarah
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Recruitment hospital [2]
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Southern Medical Day Care Ctr /ID# 132482 - Wollongong
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Recruitment hospital [3]
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Flinders Centre for Innovation /ID# 134288 - Bedford Park
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Recruitment hospital [4]
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Royal Hobart Hospital /ID# 132477 - Hobart
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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7000 - Hobart
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Recruitment outside Australia
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United Kingdom
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State/province [100]
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Norfolk
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Country [101]
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United Kingdom
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State/province [101]
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Bath
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Country [102]
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United Kingdom
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State/province [102]
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Belfast
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Country [103]
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United Kingdom
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State/province [103]
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Birmingham
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Country [104]
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United Kingdom
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State/province [104]
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Blackburn
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Country [105]
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United Kingdom
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State/province [105]
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Colchester
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Country [106]
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United Kingdom
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State/province [106]
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Cottingham
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Country [107]
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United Kingdom
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State/province [107]
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Doncaster
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Country [108]
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United Kingdom
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State/province [108]
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Great Yarmouth
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Country [109]
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United Kingdom
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State/province [109]
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Gwent
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Country [110]
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United Kingdom
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State/province [110]
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Huddersfield
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Country [111]
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United Kingdom
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State/province [111]
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London
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Country [112]
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United Kingdom
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State/province [112]
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Newcastle Upon Tyne
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Country [113]
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United Kingdom
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State/province [113]
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of veliparib plus
carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in
adults with metastatic or advanced non-squamous non-small cell lung cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02264990
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Country
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0
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Phone
0
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02264990
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