Overview

A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
Summary
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Erlotinib Hydrochloride
Gemcitabine
Criteria
Inclusion Criteria:

- adult patients, >=18 years of age;

- non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable
disease ;

- ECOG PS 2;

- adequate organ function.

Exclusion Criteria:

- prior chemotherapy or systemic anti-tumor therapy;

- hypersensitivity to erlotinib;

- any condition contraindicating the use of the study medication and/or impairing the
interpretation of results and/or leading to treatment-related complications.