A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287754

ML25575

Details and patient eligibility

About

This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=18 years of age
• Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
• Measurable disease according to RECIST criteria
• ECOG performance status 0-2
• Adequate haematological, renal and liver function

Exclusion criteria

• Previous chemotherapy or therapy against EGFR for metastatic disease
• History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
• Symptomatic cerebral metastases
• Pre-existing parenchymal lung disease such as pulmonary fibrosis
• Concomitant use of coumarins

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: erlotinib [Tarceva]