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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride

Criteria

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