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
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]
Intervention description: 150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will assess the correlation between Tarceva
      (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced,
      recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for
      advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with
      dose adjustments according to protocol depending on toxicity. Anticipated time on study
      treatment is until disease progression, unacceptable toxicity, or withdrawal due to any
      reason.
    

Eligibility criteria:

        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