Clinical Trials /

Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

NCT02395172

Description:

To demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

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 Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> (JAVELIN Lung 200)

Title

  • Brief Title: Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
  • Official Title: A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-small Cell Lung Cancer That Has Progressed After a Platinum-containing Doublet
  • Clinical Trial IDs

    NCT ID: NCT02395172

    ORG ID: 100070-004

    NCI ID: 2014-005060-15

    Trial Conditions

    Carcinoma, Non-Small-Cell Lung

    Trial Interventions

    Drug Synonyms Arms
    Avelumab Avelumab
    Docetaxel Docetaxel

    Trial Purpose

    To demonstrate superiority with regard to overall survival of avelumab versus docetaxel in
    subjects with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC)
    after failure of a platinum-based doublet.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Avelumab Experimental Avelumab
    Docetaxel Active Comparator Docetaxel

    Eligibility Criteria

    Inclusion Criteria:

    - Signed written informed consent before any trial related procedure

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

    - Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or
    7 unstained tumor slides suitable for Programmed death-ligand-1 (PD-L1) expression
    assessment

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

    - Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have
    experienced disease progression

    - Subjects must have progressed after an acceptable therapy defined as follows:

    1. Subjects must have progressed during or after a minimum of 2 cycles of 1 course
    of a platinum based combination therapy administered for the treatment of a
    metastatic disease. A history of continuation (use of a non platinum agent from
    initial combination) or switch (use of a different agent) maintenance therapy is
    permitted provided there was no progression after the initial combination. A
    switch of agents during treatment for the management of toxicities is also
    permitted provided there was no progression after the initial combination OR

    2. Subjects must have progressed within 6 months of completion of a platinum-based
    adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation
    regimen for locally advanced disease

    - Subjects with non-squamous cell NSCLC of unknown Epidermal Growth Factor Receptor
    (EGFR) mutation status will require testing (local laboratory, or central laboratory
    if local testing is not available). For subjects with a tumor that harbors an
    activating EGFR mutation, acceptable prior therapy is also defined as a treatment
    with an EGFR-targeting tyrosine kinase inhibitor (TKI) given before or after
    treatment with a platinum-based combination chemotherapy as defined above. Subjects
    with a tumor that harbors an activating EGFR mutation must have failed both the
    platinum-based doublet and the EGFR-targeting TKI. Treatment with more than 1 EGFR
    targeting TKI is acceptable

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

    - Estimated life expectancy of more than 12 weeks

    - Adequate hematological function defined by white blood cells (WBC) count >= 2.5
    10^9 per liter (/L) with absolute neutrophil count (ANC) >= 1.5 10^9/L, lymphocyte
    count >= 0.5 10^9/L, platelet count >= 100 10^9/L, and hemoglobin >= 9 gram per
    deciliter (g/dL) (may have been transfused)

    - Adequate hepatic function defined by a total bilirubin level <= 1.0 the upper limit
    of normal (ULN) range and aspartate aminotransferase (AST) and alanine
    aminotransferase (ALT) levels <= 2.5 ULN for all subjects

    - Adequate renal function defined by an estimated creatinine clearance > 30 milliliter
    per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional
    standard method)

    - Other protocol defined criteria could apply

    Exclusion Criteria:

    - In the United States only, subjects with a squamous cell histology will be excluded

    - Systemic anticancer therapy administered after disease progression during or
    following a platinum based combination, with the following exception: Subjects whose
    disease harbors an activating EGFR mutation who received an EGFR inhibitor after a
    minimum of 2 cycles of first-line platinum-based therapy. Subjects who tested
    undetermined or wild-type for EGFR but were previously treated with a TKI are not
    eligible unless retested and confirmed to be activating EGFR mutation positive

    - Subjects with non-squamous cell NSCLC whose disease harbors an anaplastic lymphoma
    kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown
    ALK status will require testing for ALK rearrangement (local laboratory, or central
    laboratory if local testing is not available) and must be determined to be ALK
    wild-type to be eligible for this trial

    - Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune
    checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
    Prior therapy with a cancer vaccine is acceptable

    - Concurrent anticancer treatment

    - Major surgery for any reason, except diagnostic biopsy, within 4 weeks of
    randomization and/or if the subject has not fully recovered from the surgery within 4
    weeks of randomization

    - Subjects receiving immunosuppressive agents (such as steroids) for any reason should
    be tapered off these drugs before initiation of the trial treatment

    - All subjects with brain metastases, except those meeting the following criteria:

    1. Brain metastases have been treated locally, and

    2. No ongoing neurological symptoms that are related to the brain localization of
    the disease

    - Active autoimmune disease that might deteriorate when receiving an immunostimulatory
    agent:

    1. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
    disease not requiring immunosuppressive treatment are eligible

    2. Subjects requiring hormone replacement with corticosteroids are eligible if the
    steroids are administered only for the purpose of hormonal replacement and at
    doses 10 mg or 10 mg equivalent prednisone per day

    3. Administration of steroids through a route known to result in a minimal systemic
    exposure are acceptable

    - Previous or ongoing administration of systemic steroids for the management of an
    acute allergic phenomenon is acceptable as long as it is anticipated that the
    administration of steroids will be completed in 14 days, or that the daily dose after
    14 days will be <= 10 mg per day of equivalent prednisone

    - Other protocol defined criteria could apply

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall survival time

    Secondary Outcome Measures

    Progression-Free Survival (PFS) Time

    Best Overall Response (BOR)

    Quality of Life EuroQuol-5D Health Outcome Questionnaire

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

    Quality Of Life Assessment EORTC Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13)

    Number of subjects with Treatment-Emergent Adverse Events 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

    Anti-PD-L1