Overview
A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Status:
Completed
Completed
Trial end date:
2005-08-01
2005-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Genentech, Inc.Treatments:
Erlotinib Hydrochloride
Criteria
Inclusion Criteria:- Written (signed) informed consent(s)
- Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
- Relapse following standard chemotherapy (combination chemotherapy such as two-drug
combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor
performance status patients)
- Age >=18 years
- ECOG performance status of 0 to 3
- Recovered from the toxic effects of prior therapy
- Able to comply with study and follow-up procedures
- Able to take oral medication
- Use of an effective means of contraception (for patients with reproductive potential)
- Granulocyte count >=1.0 x 10^9/L
- Platelet count >=75 x 10^9/L
- Serum bilirubin <1.5 x upper limit of normal (ULN)
- SGOT (AST) <2 x ULN unless elevation is clearly due to liver metastases; then SGOT
(AST) must be <5 x ULN
- Serum creatinine <=1.5 mg/dL
Exclusion Criteria:
- Any unstable systemic disease (including active infection, unstable angina, congestive
heart failure, myocardial infarction within the last 6 months, hepatic, renal, or
metabolic disease)
- Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including
gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
- History of another malignancy in the past 2 years unless the malignancy has been
adequately treated and is associated with a 5-year anticipated survival of >=90%
- Known central nervous system (CNS) metastases that have not yet been definitively
treated with surgery and/or radiation or that are symptomatic or unstable
- Nursing mothers or pregnant females