Clinical Trials /

Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations

NCT02450591

Description:

This study will test if local therapies in addition to erlotinib can improve responses and delay the time until new treatment is required. This study will also collect blood samples for research blood tests.

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

Completed

Phase:

N/A

Trial Eligibility

Document

Local Therapies for Oligometastatic Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> Harboring Sensitizing <span class="go-doc-concept go-doc-biomarker">EGFR</span> <span class="go-doc-concept go-doc-keyword">Mutations</span>

Title

  • Brief Title: Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations
  • Official Title: Pilot Study of Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations
  • Clinical Trial IDs

    NCT ID: NCT02450591

    ORG ID: 15-067

    Trial Conditions

    Oligometastatic Lung Adenocarcinoma

    Trial Interventions

    Drug Synonyms Arms
    Erlotinib Oligometastatic Non-Small Cell Lung Cancer

    Trial Purpose

    This study will test if local therapies in addition to erlotinib can improve responses and
    delay the time until new treatment is required. This study will also collect blood samples
    for research blood tests.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Oligometastatic Non-Small Cell Lung Cancer Experimental Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. Erlotinib

    Eligibility Criteria

    Inclusion Criteria:

    - Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring
    sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19
    insertions) with oligometastatic disease (5 discrete lesions of disease irrespective
    of location, inclusive of the primary lesion):

    - all sites of disease must be amenable to definitive treatment with a local therapy
    (surgical resection, stereotactic radiosurgery, ablation and conventional radiation
    therapy) as determined by surgery, interventional radiology and radiation oncology

    - all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular
    nodal disease) are considered 1 discrete lesion.

    - Each brain metastasis is included as a distinct lesion.

    - Patients already started on erlotinib are eligible as long as their sites of disease
    are determined to be eligible for definitive local therapy by consensus of the
    principal investigators within 12 weeks of the patient first taking erlotinib.

    - Lung adenocarcinoma histology confirmed at MSKCC.

    - Available archived tissue to perform molecular analysis

    - Patients without available archived tissue can have repeat biopsies to determine EGFR
    status as per standard clinical care guidelines

    - Age 18 years or older

    - Karnofsky Performance Status 70%

    - Adequate bone marrow, liver and renal function, as specified below:

    - Absolute Neutrophil Count (ANC) 1.5 x 109/L

    - Hemoglobin 8 g/dL

    - Platelets 100 x 109/L

    - Serum total bilirubin 1.5 x upper limit of normal (ULN) (except for patients with
    documented Gilbert's Syndrome)

    - AST and ALT 2.5 x ULN or 5 x ULN if liver metastases are present

    - Serum creatinine 1.5 x upper limit of normal or creatinine clearance 60ml/min for
    patients with creatinine levels above institutional normal.

    - For women of child-bearing potential, negative pregnancy test within 14 days prior to
    starting treatment

    - Men and women of childbearing age must be willing to use effective contraception
    while on treatment and for at least 3 months thereafter

    Exclusion Criteria:

    - Treatment with erlotinib prior to developing metastatic disease

    - Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR
    T790M)

    - Malignant pleural effusion or pleural disease

    - Leptomeningeal disease

    - Any site of disease that is not amenable to definitively local therapy including
    surgery or radiation therapy

    - Women who are breastfeeding or pregnant

    - Concurrent malignancies other than non-melanoma skin cancer that require active
    ongoing treatment.

    - Any medical co-morbidities that would preclude surgery or radiation therapy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    feasibility as measured by at least five patients will need to complete local therapy.

    Secondary Outcome Measures

    Trial Keywords

    Sensitizing EGFR Mutations

    Erlotinib

    Surgery

    Radiation Therapy

    15-067