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

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342965

YO25121

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

Erlotinib

Experimental group

Description:

Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.

Treatment:

Drug: Erlotinib

Chemotherapy

Active Comparator group

Description:

Participants received gemcitabine 1250 mg/m\^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m\^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.

Treatment:

Drug: Chemotherapy