Status:
COMPLETED
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01204697
Start Date
November 1 2010
End Date
July 1 2014
Last Update
November 16 2015
Active Locations (20)
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1
Lecce, Apulia, Italy, 73100
2
San Giovanni Rotondo, Apulia, Italy, 71013
3
Avellino, Campania, Italy, 83100
4
Napoli, Campania, Italy, 80131