Clareo Health | A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy greater than or equal to (≥) 12 weeks
Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
Adequate hematological , liver and renal function
You may not be if
Known hypersensitivity to erlotinib or any of its excipients
Squamous non-small cell or small cell tumors or absence of histological report
Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
Prior exposure to inhibitors of EGFR
Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
Any significant ophthalmologic 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
Radical radiotherapy with curative intent within 28 days prior to enrollment