Clinical Trials /

Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

NCT02132884

Description:

This randomized clinical trial studies how well genetic sequencing-informed targeted therapy works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify these specific types of tumor cells in patients with non-small cell lung cancer.

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

Terminated

Phase:

N/A

Trial Eligibility

Document

Genetic Sequencing-Informed <span class="go-doc-concept go-doc-intervention">Targeted Therapy</span> in Treating Patients With Stage IIIB-IV Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>

Title

  • Brief Title: Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
  • Official Title: CancerCodeTM Informed, Molecularly Targeted Therapies in Non-small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02132884

    ORG ID: CGI-068

    NCI ID: NCI-2014-00717

    Trial Conditions

    Malignant Pericardial Effusion

    Malignant Pleural Effusion

    Recurrent Non-small Cell Lung Cancer

    Stage IIIB Non-small Cell Lung Cancer

    Stage IV Non-small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    targeted therapy Arm B (genetic sequencing and targeted therapy)

    Trial Purpose

    This randomized clinical trial studies how well genetic sequencing-informed targeted therapy
    works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy
    is a type of treatment that uses drugs or other substances to identify and attack specific
    types of tumor cells that may have less harm to normal cells. Genetic sequencing may help
    identify these specific types of tumor cells in patients with non-small cell lung cancer.

    Detailed Description

    PRIMARY OBJECTIVES:

    I. The three month progression free survival (PFS) of patients treated with targeted agents
    in the second line setting based on the tumor molecular signature as defined by CancerCode
    will be 40% vs 20% with standard cytotoxic chemotherapy.

    SECONDARY OBJECTIVES:

    I. Response rate (RR). II. Overall survival (OS). III. Proportion of Arm-B patients whose
    second line therapy is changed as a result of physician access to CancerCode-50 results.

    IV. Concordance of variants identified when sequencing is performed on samples from the same
    patient collected at baseline and follow-up time points.

    OUTLINE: Patients are randomized to 1 of 2 treatment arms.

    ARM A: Patients receive standard of care therapy based on the discretion of the treating
    physician.

    ARM B: Patients undergo collection of tissue and blood samples for analysis via sequencing.
    Upon disease progression following front-line treatment, patients receive specific targeted
    therapy based on the mutational status obtained during sequencing.

    After completion of study treatment, patients are followed up every 3 months for 2 years,
    every 6 months for 1 year, and then annually thereafter.

    Trial Arms

    Name Type Description Interventions
    Arm A (standard of care treatment) Active Comparator Patients receive standard of care treatment based on the discretion of the treating physician.
    Arm B (genetic sequencing and targeted therapy) Experimental Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing. targeted therapy

    Eligibility Criteria

    Inclusion Criteria:

    - Patients with cytologically or histologically confirmed non-small cell lung cancer
    (NSCLC) - locally advanced, stage IIIB OR stage IV or stage IVM1A (malignant pleural
    or pericardial effusion or pleural implants) OR recurrence after primary surgery or
    radiotherapy (refer to 2010 American Joint Committee on Cancer [AJCC] staging, 7th
    edition [Ed])

    - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)-1.1
    criteria; previous irradiated tumor is acceptable if there is at least a 20% increase
    in the size of the previously irradiated lesion

    - Patients must be suitable candidates for treatment with standard regimens; this
    includes having adequate hematologic parameters, liver function and renal function
    based on labs that are deemed acceptable for treatment by the investigators

    - Previous radiation allowed provided that 2 weeks has passed since radiation and/or
    the patient has recovered from the side effects

    - Availability of archival diagnostic tissue (paraffin tissue block, cytospin block
    from a fine needle aspirate, or unstained slides from resected tumor, core biopsy, or
    fine needle aspirate) is required

    - Able and willing to sign an informed consent and Health Insurance Portability and
    Accountability Act (HIPAA) authorization

    - Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP
    must agree to use effective methods of contraception during active treatment and for
    the duration of the study

    Exclusion Criteria:

    - Prior treatment with any investigational or targeted therapies

    - Patients with known activating mutations in the epidermal growth factor receptor
    (EGFR) gene or anaplastic lymphoma receptor tyrosine kinase (ALK) or c-ros oncogene
    1, receptor tyrosine kinase (ROS-1) (this test [ROS-1] will be done only on select
    patients and at the discretion of treating physicians) translocation positive; the
    mutational status of all patients will be determined prior to study entry

    - Prior malignancy within the past 3 years other than complete resection of basal or
    squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate
    cancer after curative therapy

    - Prior systemic therapy within 14 days of initiating protocol treatment

    - Symptomatic brain metastasis or asymptomatic brain metastasis that are 1 cm or
    greater in size; patients with asymptomatic sub-centimeter brain metastasis are
    eligible

    - Uncontrolled or unstable medical or psychiatric co-morbidities which would clearly
    limits patients participation

    - Current, recent (within 2 weeks of enrollment of this study), or planned
    participation in an experimental drug study

    - Unstable angina

    - Pregnant (positive serum pregnancy test) or breast feeding

    - History of any disease that could lead to impaired absorption of drugs

    - Inability to comply with study and/or follow-up procedures

    - Prior allogeneic bone marrow or organ

    Minimum Eligible Age: N/A

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression free survival

    Secondary Outcome Measures

    Response rate defined by RECIST 1.1

    Proportion of Arm B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results

    Trial Keywords