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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Docetaxel; Erlotinib Hydrochloride

Criteria

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