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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 (NSCLC) and Who Are Current or Former Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02264990
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE October 9, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE October 6, 2014
Actual Primary Completion Date February 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Overall Survival (OS) in the LSP (Lung Subtype Panel) positive subgroup [ Time Frame: Up to 3 years from first dose of study drug. ]
Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Overall Survival (OS) in current smokers [ Time Frame: Up to 3 years from first dose of study drug. ]
Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Objective Response Rate (ORR) in the LSP (Lung Subtype Panel) positive subgroup and all participants [ Time Frame: Up to 3 years from first dose of study drug ]
    Objective response rate is defined as the proportion of participants with complete or partial response as determined by the investigator per Response Evaluation Criteria In Solid Tumors (version 1.1).
  • Progression Free Survival (PFS) in the LSP (Lung Subtype Panel) positive subgroup and all participants [ Time Frame: Up to 5 years from first dose of study drug ]
    Progression-free survival is defined as the number of days from participant randomization to the date the participant experiences an event of disease progression (PD) or death (all causes of mortality), if PD is not reached.
  • Overall Survival (OS) in all participants [ Time Frame: Up to 5 years from first dose of study drug. ]
    Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • Overall Survival (OS) in all participants [ Time Frame: Up to 5 years from first dose of study drug. ]
    Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
  • Progression Free Survival (PFS) in current smokers and all participants [ Time Frame: Up to 5 years from first dose of study drug ]
    Progression-free survival is defined as the number of days from participant randomization to the date the participant experiences an event of disease progression (PD) or death (all causes of mortality), if PD is not reached.
  • Objective Response Rate (ORR) in current smokers and all participants [ Time Frame: Up to 3 years from first dose of study drug ]
    Objective response rate is defined as the proportion of participants with complete or partial response as determined by the investigator per Response Evaluation Criteria In Solid Tumors (version 1.1).
Current Other Pre-specified Outcome Measures
 (submitted: May 25, 2018)
  • Change in Quality of Life in the LSP (Lung Subtype Panel) positive subgroup and in all participants [ Time Frame: From Screening (prior to dosing) up to 2 years ]
    Participants will answer the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) and the Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 questionnaire.
  • Duration of overall response (DOR) in the LSP (Lung Subtype Panel) positive subgroup and in all participants [ Time Frame: Up to 3 years from randomization. ]
    The duration of overall response for a participant is defined as the number of days from when the criteria is met for a complete or partial response (whichever occurs first), to the date that progressive disease (PD) is objectively documented.
  • Change in Eastern Cooperative Oncology Group (ECOG) Performance Status in the LSP (Lung Subtype Panel) positive subgroup and in all participants [ Time Frame: From Screening (prior to dosing) up to 2 years ]
Original Other Pre-specified Outcome Measures
 (submitted: October 9, 2014)
  • Duration of overall response (DOR) in current smokers and in all participants [ Time Frame: Up to 3 years from randomization. ]
    The duration of overall response for a participant is defined as the number of days from when the criteria is met for a complete or partial response (whichever occurs first), to the date that progressive disease (PD) is objectively documented.
  • Change in Eastern Cooperative Oncology Group (ECOG) Performance Status in current smokers and in all participants [ Time Frame: From Screening (prior to dosing) up to 2 years ]
  • Change in Quality of Life in current smokers and in all participants [ Time Frame: From Screening (prior to dosing) up to 2 years ]
    Participants will answer the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) and the Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 questionnaire.
 
Descriptive Information
Brief Title  ICMJE 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 (NSCLC) and Who Are Current or Former Smokers
Official Title  ICMJE 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
Brief Summary This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell lung cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-squamous Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Paclitaxel
    Intravenous infusion
  • Drug: Pemetrexed
    Intravenous infusion
    Other Name: Alimta
  • Drug: Carboplatin
    Intravenous infusion
  • Drug: Cisplatin
    Intravenous infection
  • Drug: Veliparib
    Oral Capsule
    Other Name: ABT-888
Study Arms  ICMJE
  • Experimental: Veliparib/Carboplatin/Paclitaxel
    veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Veliparib
  • Active Comparator: Investigator's choice of platinum doublet
    Either carboplatin and paclitaxel, cisplatin and pemetrexed, or carboplatin and pemetrexed on Day 1 of a 21 day cycle.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Pemetrexed
    • Drug: Carboplatin
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2018)
595
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
525
Actual Study Completion Date  ICMJE February 21, 2020
Actual Primary Completion Date February 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

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 EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement.
  • Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Czechia,   Denmark,   Finland,   Germany,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   France
 
Administrative Information
NCT Number  ICMJE NCT02264990
Other Study ID Numbers  ICMJE M14-359
2014-002565-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: 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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP