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

• Overall survival [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
• Objective response rate (ORR), tumour assessments according to RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Duration of response, tumour assessments according to RECIST criteria [ Time Frame: from response to progressive disease ] [ Designated as safety issue: No ]
• Safety: Incidence of adverse events [ Time Frame: through study (up to 3 years) ] [ Designated as safety issue: No ]

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.

• Drug: erlotinib [Tarceva]
  150 mg/day orally as monotherapy
• Drug: erlotinib [Tarceva]
  150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
• Drug: docetaxel
  75 mg/m2 intravenously every 3 weeks for 4 cycles

• Experimental: A
  Intervention: Drug: erlotinib [Tarceva]
• Experimental: B
  Interventions:

  • Drug: erlotinib [Tarceva]
  • Drug: docetaxel

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
• 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/metatstatic 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