A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)

A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy

This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.

Inclusion Criteria:

• male patients, >/=18 years of age
• former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
• locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
• prior platinum-based therapy for advanced NSCLC
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

• uncontrolled symptomatic central nervous system (CNS) metastases
• prior therapy against epidermal growth factor receptor (EGFR)
• >1 prior chemotherapy for advanced/metastatic NSCLC
• radiotherapy <28 days prior to enrollment
• history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of >5 years
• not fully treated eye inflammation or infection, or predisposing conditions