An expanded access program of Tarceva (erlotinib) in patients with advanced stage IIIB/ IV non-small cell lung cancer (NSCLC)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5000

Inclusion Criteria

•Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC
•Patients must have evidence of disease but measurable disease is not mandatory
•18 years of age or older
•ECOG performance status of 0 - 3
•Life expectancy of at least 12 weeks
•Patients with advanced stage IIIB /IV Non Small Cell lung cancer who have received at least one course of standard systemic chemotherapy or radiation therapy or who are in the investigator’s opinion not medically suitable for chemotherapy or radiotherapy, or are ineligible for another trial with erlotinib
•No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
•Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
•Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
•Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
•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. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient’s treating Oncologist and the ophtamologist.
•Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
•Nursing mothers

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide Tarceva to patients with advanced stage IIIB /IV Non Small Cell Lung Cancer who have received at least one course of standard systemic chemotherapy or radiation therapy or who are in the investigator’s opinion not medically suitable for chemotherapy or radiotherapy, or are ineligible for another trial with erlotinib. No more than 2 prior chemotherapy regimens are permissible.<br>;Secondary Objective: •Best response (as per investigator’s assessment) <br>•Time to progression (TTP)<br>•Survival <br>•Safety (SAEs, Adverse Events leading to premature withdrawal, unexpected Tarceva related AEs and Tarceva related rash)<br>;Primary end point(s): The patients will receive Tarceva as long as they, in the investigator’s opinion, are benefiting from this therapy.

Secondary Outcome Measures

Name	Time	Method

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