A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cisplatin; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Adult participants, ≥ 18 years of age.

• Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.

• Presence of epidermal growth factor receptor (EGFR) mutations in tumours.

• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.

• European Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

• Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).

• Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.

• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.

• Any inflammatory changes of the surface of the eye.

• ≥ Grade 2 peripheral neuropathy.

• History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.

• Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.

• Human immunodeficiency virus (HIV) infection.

• Pregnant, nursing, or lactating women.