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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

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: NCT02106546
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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).

Condition or disease Intervention/treatment Phase
Squamous Non-Small Cell Lung Cancer Drug: Carboplatin Drug: Veliparib Drug: Paclitaxel Drug: Placebo to veliparib Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : April 10, 2014
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Carboplatin
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Drug: Veliparib
Capsules taken orally twice a day, 12 hours apart.
Other Name: ABT-888

Drug: Paclitaxel
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
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.
 Drug: Carboplatin
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Drug: Paclitaxel
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².

Drug: Placebo to veliparib
Capsules taken orally twice a day, 12 hours apart.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) in current smokers [ Time Frame: Up to 3 years from first dose of study drug ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) in all subjects [ Time Frame: Up to 3 years from first dose of study drug ]
    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.

  2. Progressive-Free Survival (PFS) in current smokers and in all subjects [ Time Frame: Up to 3 years from first dose of study drug ]
    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.

  3. Objective Response Rate (ORR) in current smokers and in all subjects [ Time Frame: Up to 3 years from first dose of study drug ]
    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)


Other Outcome Measures:
  1. Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30). [ Time Frame: From Screening (prior to dosing) up to 2 years ]
  2. Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13). [ Time Frame: From Screening (prior to dosing) up to 2 years ]
  3. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: From Screening (prior to dosing) up to 2 years ]
  4. Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) [ Time Frame: From Screening (prior to dosing) up to 2 years ]
  5. Duration of Response [ Time Frame: From complete or partial response to disease progression (up to 3 years from randomization). ]
    The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  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).

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.
Contacts and Locations
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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): NCT02106546


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02106546    
Other Study ID Numbers: M11-089
2013-005020-42 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: October 2020
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)
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
veliparib
carboplatin
paclitaxel
Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)
Overall Survival
Advanced
 Metastatic
ABT-888
Squamous
Randomized
non-small cell lung cancer
placebo controlled
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
 Carboplatin
Veliparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors