Overview

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

Status:
Completed
Trial end date:
2017-01-31
Target enrollment:
0
Participant gender:
All
Summary
This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.
Phase:
Phase 2
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 non-small cell lung cancer

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

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

- Life expectancy over >/=12 weeks

- Adequate hematological, liver, or kidney function

Exclusion Criteria:

- Previous therapy against epidermal growth factor receptor for metastatic disease

- Treatment with investigational drug during the 3 weeks before enrollment

- History of neoplasm

- Patients with symptomatic cerebral metastases

- Unstable systemic disease