Clinical Trials /

Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)

NCT02576574

Description:

The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Avelumab</span> in First-line Non-<span class="go-doc-concept go-doc-disease">Small Cell Lung Cancer </span>(JAVELIN Lung 100)

Title

  • Brief Title: Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)
  • Official Title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02576574

    ORG ID: EMR 100070-005

    NCI ID: 2015-001537-24

    Trial Conditions

    First Line Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Avelumab Anti-PD-L1, MSB0010718C Avelumab
    Pemetrexed Platinum-containing chemotherapy regimen
    Paclitaxel Platinum-containing chemotherapy regimen
    Gemcitabine Platinum-containing chemotherapy regimen
    Gemcitabine Platinum-containing chemotherapy regimen
    Carboplatin Platinum-containing chemotherapy regimen
    Cisplatin Platinum-containing chemotherapy regimen
    Carboplatin Platinum-containing chemotherapy regimen

    Trial Purpose

    The purpose of this study is to demonstrate superiority with regard to progression free
    survival (PFS) based on an Independent Review Committee (IRC) assessment of avelumab versus
    platinum-based doublet in non-small cell lung cancer (NSCLC) subjects with Programmed death
    ligand 1+ (PD-L1+) tumors.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Avelumab Experimental Avelumab
    Platinum-containing chemotherapy regimen Active Comparator Platinum-containing chemotherapy regimen: Investigator's choice platinum containing chemotherapy regimen to be administered consisting of one of the following: Non-squamous tumor histology Pemetrexed (500 mg/m^2) +cisplatin (75 mg/m^2) or carboplatin (AUC 6 mg/mL*min) Squamous tumor histology Paclitaxel (200 mg/m^2) +carboplatin (AUC 6 mg/mL*min) Gemcitabine (1250 mg/m^2)+ cisplatin (75 mg/m^2) Gemcitabine (1000 mg/m^2 )+carboplatin (AUC 5 mg/mL*min) Pemetrexed, Paclitaxel, Gemcitabine, Gemcitabine, Carboplatin, Cisplatin, Carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Male or female subjects aged greater than or equal to (>=) 18 years

    - Tumor determined to be positive for PD-L1 expression per the evaluation of a central
    laboratory

    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

    - At least 1 lesion that can be measured.

    - Subjects with histologically confirmed metastatic or recurrent non-small cell lung
    cancer (NSCLC)

    - Subjects must not have received any treatment for systemic lung cancer, and have an
    estimated life expectancy of more than 12 weeks

    - Other protocol defined criteria could apply

    Exclusion Criteria:

    - Subjects whose disease harbors an activating epidermal growth factor receptor (EGFR)
    mutation, or an anaplastic lymphoma kinase (ALK) rearrangement

    - Prior therapy with any antibody or drug targeting T cell coregulatory proteins,
    concurrent anticancer treatment, or immunosuppressive agents

    - Subjects with known severe hypersensitivity reactions to monoclonal antibodies,
    history of anaphylaxis, or uncontrolled asthma, and persisting toxicity related to
    prior therapy of Grade greater than (>) 1

    - Subjects with brain metastases are excluded, except those meeting the following
    criteria: brain metastases that have been treated locally and are clinically stable
    for at least 2 weeks prior to enrollment, subjects must be either off steroids or on
    a stable or decreasing dose of less than (<) 10 mg daily prednisone (or equivalent),
    and do not have ongoing neurological symptoms that are related to the brain
    localization of the disease

    - Other protocol defined criteria could apply

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Secondary Outcome Measures

    Best Overall Response (BOR)

    Overall Survival (OS)

    Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire

    Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status

    Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    Number of subjects with Treatment-Emergent Adverse Events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

    Trial Keywords

    Avelumab

    MSB0010718C

    Non-Small Cell Lung Cancer