Lung Cancer, Non-small-cell Lung Carcinoma
Conditions
Keywords
Advanced non-small cell lung cancer
Brief 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.
Interventions
Sponsors
Genentech, Inc.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed