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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 : Active, not recruiting
First Posted : October 15, 2014
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Non-squamous Non-small Cell Lung Cancer Drug: Paclitaxel Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin Drug: Veliparib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 10, 2014
Estimated Primary Completion Date : July 26, 2019
Estimated Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Veliparib/Carboplatin/Paclitaxel
veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
Drug: Paclitaxel
Intravenous infusion

Drug: Carboplatin
Intravenous infusion

Drug: Veliparib
Oral Capsule
Other Name: ABT-888

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.
Drug: Paclitaxel
Intravenous infusion

Drug: Pemetrexed
Intravenous infusion
Other Name: Alimta

Drug: Carboplatin
Intravenous infusion

Drug: Cisplatin
Intravenous infection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264990


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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02264990     History of Changes
Other Study ID Numbers: M14-359
2014-002565-30 ( EudraCT Number )
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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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

Keywords provided by AbbVie:
veliparib
carboplatin
paclitaxel
cisplatin
pemetrexed
Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)
Metastatic
Non-squamous
Non-small cell lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Veliparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors