Overview

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Erlotinib Hydrochloride
Mitogens
Criteria
Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung
cancer with mutations in the tyrosine kinase domain of the epidermal growth factor
receptor (EGFR)

- At least one measurable lesion according to RECIST criteria

- European Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate hematological, liver and renal function

- Patients with stable cerebral metastases who have received surgical or radiotherapy
will be eligible

Exclusion Criteria:

- Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or
adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before
entering the study)

- History of another neoplasm except for carcinoma in situ of the cervix, adequately
treated basal cell skin carcinoma, radically treated prostate carcinoma with good
prognosis (Gleason disease in the last 5 years

- Symptomatic cerebral metastases

- Any significant ophthalmologic abnormality

- Use of coumarins

- Pregnant or breast-feeding women

- Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and
carcinomatosis (if this is the only presence of the disease)