Last updated on June 2006

First-Line EGFR-1 Tyrosine Kinase Inhibition in Patients With NSCLC With Mutant EGFR Gene


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adenocarcinoma | Non-Small Cell Lung Cancer | Lung Neoplasms | Bronchiolo-Alveolar
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Histological or cytological diagnosis of inoperable, locally advanced, recurrent or
    metastatic (Stage IIIB or Stage IV) adenocarcinoma of the lung in a patient with a
    moking history of < 15 years and quit smoking > 1 year before diagnosis.
    Evidence of disease but measurable disease is not mandatory.
    18 years of age or older.
    ECOG performance status of 0 – 3.
    Patients not eligible for standard curative-intent treatment with surgery or
    chemo-radiotherapy.
    Life expectancy ³ 3 months.
    Prior therapy for NSCLC allowed for primary disease: surgery and radiotherapy and
    adjuvant or proto-adjuvant chemotherapy completed > 6 months before inclusion
    Adequate bone marrow, hepatic and renal function:
    Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L Serum bilirubin must be <
    5 upper limit of normal (ULN). If alkaline phosphatase is > 2.5 x ULN, SGOT (AST) and
    SGPT (ALT) must be < 1.5 x ULN.
    Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.
    Ability for giving informed consent for participating in the study and filling out
    FACT-L quality of life scales.
    Able to comply with study and follow-up procedures.
    Availability of tumour biopsy sample (fixed in formalin and, if possible, also snap
    frozen tumour sample). If frozen samples are available, these will be collected by
    central data management.
    Signed Informed Consent for performing mutation analysis and subsequent biomarker
    analysis.
    Separate signed Informed Consent for participation in the treatment phase of the
    tudy.
    Ability to take oral medication.
    For all females of childbearing potential a negative pregnancy test must be obtained
    within 48 hours before starting therapy.

You may not be eligible for this study if the following are true:

  • Patients for whom urgent chemotherapy or radiotherapy is deemed necessary (e.g.
    rapidly progressive disease).
    Current symptomatic central nervous disorder, brain or leptomeningeal metastasis.
    Pre-existing symptomatic interstitial lung disease, not related to the current
    malignancy.
    Patients with a history of other malignancies, except patients with basal cell
    carcinoma of the skin or in situ carcinoma of the cervix with a disease free interval
    of ³ 5 years. Patients with a prior history of other good prognosis malignancies more
    than 5 years since end of treatment and in un-maintained complete remission also can
    be considered for inclusion
    Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (small
    molecule or monoclonal antibody) or chemotherapy
    Significant malabsorption syndrome or disease affecting the gastrointestinal tract
    function
    Pregnant or breast-feeding women; for women in reproductive condition, a negative
    pregnancy test is required.
    Concomitant food or drug intake which potentially impairs absorption and
    metabolisation of RTKI's.
    Participation in another clinical trial with any investigational drug within 30 days
    prior to study screening.
    Any unstable systemic disease (including active infection, grade 4 hypertension,
    unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
    Any significant ophthalmological abnormality, especially severe dry eye syndrome,
    keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other
    disorder likely to increase the risk of corneal epithelial lesions.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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