A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer Read More

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