A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250119

ML25279

2010-021120-96

Details and patient eligibility

About

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

Enrollment: 688 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)
• ECOG performance status 0-3
• Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study
• Adequate haematological, liver and renal function
• Female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception
• Male patients must be surgically sterile or agree to use a barrier method of contraception

Exclusion criteria

• Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor)
• Symptomatic cerebral metastases
• Pregnant or lactating women
• Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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688 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: erlotinib [Tarceva]