A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
NCT ID: NCT01204697
Last Updated: 2015-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2010-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
erlotinib [Tarceva]
150 mg/day orally as monotherapy
B
docetaxel
75 mg/m2 intravenously every 3 weeks for 4 cycles
erlotinib [Tarceva]
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
Interventions
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docetaxel
75 mg/m2 intravenously every 3 weeks for 4 cycles
erlotinib [Tarceva]
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
erlotinib [Tarceva]
150 mg/day orally as monotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Lecce, Apulia, Italy
San Giovanni Rotondo, Apulia, Italy
Avellino, Campania, Italy
Napoli, Campania, Italy
Parma, Emilia-Romagna, Italy
Aviano (PN), Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Cremona, Lombardy, Italy
Milan, Lombardy, Italy
Monza, Lombardy, Italy
Pavia, Lombardy, Italy
Sondalo, Lombardy, Italy
Macerata, The Marches, Italy
Lido di Camaiore, Tuscany, Italy
Pisa, Tuscany, Italy
Pontedera, Tuscany, Italy
Treviso, Veneto, Italy
Vicenza, Veneto, Italy
Countries
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Other Identifiers
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ML21869
Identifier Type: -
Identifier Source: org_study_id
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