Overview

An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Erlotinib Hydrochloride
Criteria
Inclusion Criteria:

- Adults greater than or equal to (≥) 18 years of age

- Histologically or cytologically documented inoperable, locally advanced, metastatic,
or recurrent NSCLC

- Previous treatment with no more than 2 prior chemotherapy regimens

Exclusion Criteria:

- Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1
(HER1)/epidermal growth factor receptor (EGFR) inhibitors

- Inability to take oral medication

- Any other malignancies within 5 years