Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSI Pharmaceuticals
• Treatments: Carboplatin; Erlotinib Hydrochloride; Paclitaxel

Criteria

Inclusion Criteria:

• Age >= 18

• Histologically or cytologically documented non-small cell lung cancer (NSCLC)

• Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2

• Radiologically measurable or evaluable disease No prior chemotherapy

• 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening

• Tumor tissue block or fine needle aspirate

Exclusion Criteria:

• Any concurrent anticancer therapy or radiation

• Other active malignancy

• Uncontrolled brain metastases

• GI abnormalities

• Severe abnormalities of the cornea

• Significant cardiac disease

• Active infection