Clinical Trials /

Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

NCT02584634

Description:

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

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

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of <span class="go-doc-concept go-doc-intervention">Avelumab</span> In Combination With Either <span class="go-doc-concept go-doc-intervention">Crizotinib</span> Or <span class="go-doc-concept go-doc-intervention">PF-06463922</span> In Patients With <span class="go-doc-concept go-doc-disease">NSCLC</span>. (Javelin Lung 101)

Title

  • Brief Title: Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
  • Official Title: A Phase 1b/2, Open-label, Dose-finding Study To Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab (msb0010718c) In Combination With Either Crizotinib Or Pf-06463922 In Patients With Advanced Or Metastatic Non-small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02584634

    ORG ID: B9991005

    NCI ID: 2015-001879-43

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Avelumab MSB0010718C Group A, Group B
    PF-06463922 Group B
    Crizotinib PF-02341066 Group A

    Trial Purpose

    The purpose of this study is to evaluate the safety and efficacy of avelumab when combined
    with either crizotinib or PF-06463922.

    Detailed Description

    This is a Phase 1b/2, open label, multi center, multiple dose, safety, pharmacokinetic and
    pharmacodynamic study of Group A and Group B in cohorts of adult patients with locally
    advanced or metastatic NSCLC.

    Trial Arms

    Name Type Description Interventions
    Group A Experimental ALK negative Non-Small Cell Lung Cancer Avelumab, Crizotinib
    Group B Experimental ALK positive Non-Small Cell Lung Cancer Avelumab, PF-06463922

    Eligibility Criteria

    - Inclusion Criteria

    - Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and
    Group B must be ALK positive NSCLC

    - Mandatory tumor tissue available

    - At least one measurable lesion

    - ECOG Performance status 0 or 1

    - Adequate bone marrow, renal, liver and pancreatic function

    - Negative pregnancy test for females of childbearing potential

    Exclusion Criteria:

    - No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
    anti-CTLA-4 antibody.

    - No Severe or Chronic medical conditions including gastrointestinal abnormalities
    or significant cardiac history

    - No active infection requiring systemic therapy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    First two cycles dose limiting toxicities (DLTs) for Group A and Group B

    Confirmed Overall Response (OR) per RECIST v.1.1 for Group A

    Secondary Outcome Measures

    Disease Control (DC)

    Confirmed Overall Response (Group B)

    Overall Survival

    AUClast

    AUCtau

    Cmax

    Tmax

    ta

    Ctrough

    CL/Fa

    Vz/Fa

    MRAUCtau

    MRCmax

    tumor tissue biomarkers

    Duration of Response (DR)

    Time to Treatment Response (TTR)

    Progression Free Survival (PFS)

    Trial Keywords

    Non-Small Cell Lung Cancer

    NSCLC

    ALK

    avelumab

    crizotinib

    PF-06463922