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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

NCT02264990

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

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 Investigator's Choice of Standard <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> in Subjects Receiving First Cytotoxic <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> for Metastatic or Advanced Non-Squamous Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> Who Are Current or Former Smokers

Title

  • Brief Title: 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 Who Are Current or Former Smokers
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02264990

    ORG ID: M14-359

    NCI ID: 2014-002565-30

    Trial Conditions

    Non-squamous Non-small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Veliparib ABT-888 Veliparib/Carboplatin/Paclitaxel
    Carboplatin Veliparib/Carboplatin/Paclitaxel, Investigator's choice of platinum doublet
    Paclitaxel Veliparib/Carboplatin/Paclitaxel, Investigator's choice of platinum doublet
    Cisplatin Investigator's choice of platinum doublet
    Pemetrexed Alimta Investigator's choice of platinum doublet

    Trial Purpose

    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
    current or former smokers who are receiving their first cytotoxic therapy for metastatic or
    advanced non-squamous non-small cell lung cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Veliparib/Carboplatin/Paclitaxel Experimental veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle Veliparib, Carboplatin, Paclitaxel
    Investigator's choice of platinum doublet Active Comparator Either carboplatin and paclitaxel, cisplatin and pemetrexed, or carboplatin and pemetrexed on Day 1 of a 21 day cycle. Carboplatin, Paclitaxel, Cisplatin, Pemetrexed

    Eligibility 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Survival (OS) in current smokers

    Secondary Outcome Measures

    Overall Survival (OS) in all participants

    Progression Free Survival (PFS) in current smokers and all participants

    Objective Response Rate (ORR) in current smokers and all participants

    Trial Keywords

    Non-squamous

    Non-small cell lung cancer

    veliparib

    carboplatin

    paclitaxel

    pemetrexed

    Metastatic

    cisplatin

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