Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Age \>=18 years
Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
Measurable or non-measurable disease
ECOG performance status of 0 or 1
Life expectancy of \>=3 months
\>= 3 weeks since any prior surgery or radiotherapy (\>=2 weeks for patients who receive \<=30 Gy of radiotherapy involving \<25% of the marrow reserve)
Use of an effective means of contraception (women of childbearing potential)
Able to comply with study and follow-up procedures
You may not be if
Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
Symptomatic or untreated brain metastases
Prior systemic chemotherapy for NSCLC
Prior exposure to agents directed at the HER axis (e.g., ZD1839 \[Iressa\], C225 \[Cetuximab\], Trastuzumab \[Herceptin\])
Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
Pregnancy or lactation
Any of the following abnormal baseline hematologic values:
Granulocytes count \<=1500/uL
Platelet count \<100,000/uL
Any of the following abnormal baseline liver function tests:
Serum bilirubin \>1.5× upper limit of normal (ULN)
Serum ALT and AST \>=2.5× ULN (\>5× ULN if due to liver metastases)
Alkaline phosphatase \>=2.5× ULN
Other baseline laboratory values:
Serum creatinine \>1.5× ULN or creatinine clearance \<60 mL/min
