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

OSI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: carboplatin; Drug: Tarceva; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294762

OSI-774-203

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Erlotinib

Experimental group

Description:

150 mg erlotinib daily

Treatment:

Drug: Tarceva

Erlotinib + chemotherapy (intercalated)

Experimental group

Description:

carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity

Treatment:

Drug: carboplatin

Drug: Tarceva

Drug: paclitaxel