A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression. Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Key facts

Study ID

NCT00585533

Run by

University of Utah

People needed

40

Starts

2004-06-01

Expected to finish

2012-03-01

Last updated by the study team

2013-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Performance status 0-1.
• Weight Loss < 10% in preceding 3 months
• Age 18 years and older.
• Adjuvant chemotherapy allowed if > 6 months from protocol entry
• Adequate Organ Function
• Liver enzymes < 2X normal, bilirubin = normal
• Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
• Creatinine <2.0 mg

You may not qualify if…

• Not pregnant or lactating.
• No Clinical Brain Metastases
• No prior chemotherapy for systemic disease
• Imminent need for chemotherapy for impending organ dysfunction is not allowed

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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