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Randomized, Double-Blind, Multicenter, 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

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ClinicalTrials.gov Identifier: NCT02106546
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a 2 arm Phase 3 study 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 subjects with advanced or metastatic squamous NSCLC.

Condition or disease Intervention/treatment Phase
Squamous Non-Small Cell Lung Cancer Drug: carboplatin Drug: veliparib Drug: paclitaxel Drug: placebo Phase 3

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
Estimated Primary Completion Date : March 28, 2018
Estimated Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: veliparib and carboplatin and paclitaxel
veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
Drug: carboplatin
Intravenous infusion
Drug: veliparib
Oral Capsule
Other Name: ABT-888
Drug: paclitaxel
Intravenous infusion
Placebo Comparator: placebo and carboplatin and paclitaxel
placebo on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle
Drug: carboplatin
Intravenous infusion
Drug: paclitaxel
Intravenous infusion
Drug: placebo
Oral Capsule



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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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.

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


  Show 227 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02106546     History of Changes
Other Study ID Numbers: M11-089
2013-005020-42 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
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:
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
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors