NCT lookup

Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC)
* Presence of epidermal growth factor receptor (EGFR) mutations
* Previously untreated with any systemic anti-neoplastic therapy for advanced disease
* Last dose of a prior systemic anti-neoplastic therapy for early-stage disease \>/= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy
* A life expectancy of at least 12 weeks
* Able to comply with the study and its follow-up procedures
* Female participants had to be postmenopausal (24 months of amenorrhea), surgically sterile or agree to use a physical method of contraception. Male participants had to be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 24 months) had to have a negative pregnancy test (urine or serum) within 3 days prior to erlotinib treatment initiation in the study. Male and female participants had to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib. Acceptable methods of contraception included an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms)

Exclusion Criteria:

* Pregnant or breast feeding women
* Granulocyte count \<1.5 x 109/L and platelet count \<100\*10\^9/L
* Serum bilirubin \>1.5 upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 \* ULN (or \>5 \* ULN if clearly attributable to liver metastasis)
* Serum creatinine \>1.5 ULN or creatinine clearance \<60 mL/min
* Known allergy or other adverse reaction to study drug or any other related compound
* Any significant unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease)
* Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy)
* Newly diagnosed or not yet definitively treated (i.e. stable disease \>/= 2 months) CNS metastases or spinal cord compression
* Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study)
* Participants who could not take oral medication, who required intravenous alimentation, had had prior surgical procedures affecting absorption, or had active peptic ulcer disease
* Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

• Afula, Israel
• Ashkelon, Israel
• Beersheba, Israel
• Haifa, Israel
• Haifa, Israel
• Holon, Israel
• Jerusalem, Israel
• Jerusalem, Israel
• Kfar Saba, Israel
• Nahariya, Israel
• Ramat Gan, Israel
• Rehovot, Israel
• Sefad, Israel
• Tel Aviv, Israel
• Tiberias, Israel
• Ẕerifin, Israel