A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 (Erlotinib) in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
I. Prospectively identify downstream markers of EGFR linked signaling pathways that are
predictive of response to OSI-774 (Erlotinib) in this population.
I. Estimate antitumor objective response rate per RECIST. II. Estimate disease control rate
(CR+PR+SD). III. Estimate time to progression and overall survival. IV. Estimate if a grade
2 rash is a predictor of response to OSI-774 (Erlotinib) and of patient survival.
V. Assess safety profile of OSI-774 (Erlotinib) in this population. VI. To determine whether
smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774
OUTLINE: This is a pilot, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at
baseline, and then every 3 months during study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years, and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rates and distribution of the mitogen-activated protein kinase (MAPK)/extracellular-signal-regulated kinase (Erk)-phosphorylated expression groups based on the Response Evaluation Criteria in Solid Tumors (RECIST)
A Fisher's exact test with a two-sided 5% type I error rate will be calculated.
Up to 5 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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