Clinical trial NCT00453362 (phase 1/phase 2, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: erlotinib hcl
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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