A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult participants, \>/= 18 years of age
Stage IV or recurrent non-small cell lung cancer (NSCLC)
Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
Measurable disease (at least one lesion \>= 10 mm in longest diameter)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate hematological, renal and liver function
You may not be if
Patients with T790M single mutation only
Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
Symptomatic or uncontrolled central nervous system (CNS) metastases
Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
Any significant ophthalmologic abnormality
Pre-existing parenchymal lung disease such as pulmonary fibrosis
Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)
Clareo Health | A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations