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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

NCT02106546

Description:

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).

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02106546

Trial Eligibility

Document

Randomized, Double-Blind, Multicenter, Study Comparing <span class="go-doc-concept go-doc-intervention">Veliparib</span> Plus <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Paclitaxel</span> Versus <span class="go-doc-concept go-doc-intervention">Placebo</span> Plus <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Paclitaxel</span> in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>

Title

  • Brief Title: 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
  • 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)

    • Clinical Trial IDs

    NCT ID: NCT02106546

    ORG ID: M11-089

    NCI ID: 2013-005020-42

    Trial Conditions

    Squamous Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    veliparib ABT-888 veliparib and carboplatin and paclitaxel
    carboplatin veliparib and carboplatin and paclitaxel, placebo and carboplatin and paclitaxel
    paclitaxel veliparib and carboplatin and paclitaxel, placebo and carboplatin and paclitaxel
    placebo placebo and carboplatin and paclitaxel

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    veliparib and carboplatin and paclitaxel Experimental veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle veliparib, carboplatin, paclitaxel
    placebo and carboplatin and paclitaxel Placebo Comparator placebo on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle carboplatin, paclitaxel, placebo

    Eligibility 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 for advanced or metastatic NSCLC.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Survival (OS)

    Secondary Outcome Measures

    Progression-Free Survival (PFS)

    Objective Response Rate (ORR)

    Trial Keywords

    Advanced

    carboplatin

    Overall Survival

    non-small cell lung cancer

    paclitaxel

    placebo controlled

    Randomized

    Squamous

    veliparib

    ABT-888

    Metastatic

    Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)