Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Roche Pharma AG
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed Informed Consent Form(s)
Histologically confirmed NSCLC
Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Age ≥ 18 years
Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia)
Ability to comply with the study and follow-up procedures, including all specified imaging studies
Ability to take oral medication
Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)
Life expectancy ≥ 3 months
Measurable disease on computed tomography (CT)
At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT
Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility
You may not be if
Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)
Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered
Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
Uncontrolled diabetes
Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)
Pregnancy or lactation
History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival \> 90%
Claustrophobia
Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study
