Last updated on February 2012

Tarceva Italian Lung Optimization tRial

Are you eligible to participate in this study?

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

  • Conditions: Non Small Cell Lung Cancer (NSCLC)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Age 18 years or older
    Histological or cytological confirmation of NSCLC (may be from initial diagnosis of
    NSCLC or subsequent biopsy). Only patients with available tissue samples may be
    included in the study
    Absence of EGFR mutations of exons 19 or 21 (randomization)
    Locally advanced or metastatic NSCLC, not amenable to curative surgery or
    One prior platinum-based at adequate doses and taxane free regimen
    Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated
    or non-measurable disease
    ECOG-PS 0-2
    ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L
    Bilirubin level either normal or <1.5xULN
    AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)
    Serum creatinine <1.5xULN
    Effective contraception for both, male and female pts, if the risk of conception
    Recovery from all acute toxicities of prior therapies
    Provision of written informed consent to the analysis of biological markers
    Provision of written informed consent to enter the randomized part of the study

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

  • Prior therapy with an experimental agent whose primary mechanism of action is
    inhibition of EGFR or its associated tyrosine kinase
    Prior chemotherapy with taxanes
    Newly diagnosed CNS metastases that have not yet been treated with surgery and/or
    radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord
    compression may be considered if they have evidence of clinically SD (no steroid
    therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since
    completion of prior radiotherapy or persistence of any radiotherapy related toxicity
    Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion
    of the investigator, makes it inappropriate for the patient to be enrolled in the
    tudy Known severe hypersensitivity to erlotinib or any of the excipients of this
    Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with
    polysorbate 80, or any of the excipients of docetaxel
    Other co-existing malignancies or malignancies diagnosed within the last 5 years with
    the exception of basal cell carcinoma or cervical cancer in situ
    Unable to swallow tablets
    Any evidence of clinically active interstitial lung disease (patients with chronic,
    table, radiographic changes who are asymptomatic or patients with uncomplicated
    progressive lymphangitic carcinomatosis need not be excluded)
    As judged by the investigator, any evidence of severe or uncontrolled systemic
    disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal
    As judged by the investigator, any inflammatory changes of the surface of the eye
    Evidence of any other significant clinical disorder or laboratory finding that makes
    it undesirable for the patient to participate in the study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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