Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Tarceva (erlotinib)
Type: Drug
Overall Status
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.


Primary: Objective response rate

Secondary: Progression free survival, Overall survival and Safety of Tarceva
Detailed Description
Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age 18 years.

- Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).

- Measurable disease.

- Written informed consent must be obtained prior to the inclusion into the trial.

- Karnofsky performance status of 80%.

- Patients must have been treated with no prior chemotherapy or radioterapy.

- Patients must have adequate bone marrow, liver and renal function.

- Bone Marrow: WBC > 3000 x 103/mm3,

- Platelets > 100 x 103/mm3,

- Hgb > 10.0 gm/dl,

- ANC >1500 x 103/mm3,

- Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal,

- Renal:Creatinine < 1.5 mg/dl (132 µmol/l).

Exclusion Criteria:

- Female patients who are pregnant or lactating.

- Patients who have used other investigational agents within 21 days prior to study entry.

- Patients who have received prior treatment with erlotinib or other anti-EGFR agent.

- Significant comorbidity.
Grupo Gallego de Cancer de Pulmon
Santiago de Compostela, A Coruña, Spain
Status: Recruiting
Contact: Joaquin Casal, MD -
Start Date
January 2006
Grupo Gallego de Cancer de Pulmon
Grupo Gallego de Cancer de Pulmon
Record processing date processed this data on July 28, 2015 page