A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy
NCT ID: NCT02013206
Last Updated: 2014-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2006-09-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Never Smokers
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
erlotinib [Tarceva]
Erlotinib tablets taken orally once daily in the morning.
Current/Former Smokers
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
erlotinib [Tarceva]
Erlotinib tablets taken orally once daily in the morning.
Interventions
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erlotinib [Tarceva]
Erlotinib tablets taken orally once daily in the morning.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
* no previous chemotherapy.
Exclusion Criteria
* clinical evidence of brain metastasis;
* any unstable systemic disease;
* unable to take oral medication;
* any significant ophthalmological abnormality.
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_CHAIR
Hoffmann-La Roche
Locations
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Marseille, , France
Villejuif, , France
Hamburg, , Germany
Milan, , Italy
Rozzano, , Italy
Amsterdam, , Netherlands
Maastricht, , Netherlands
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Manchester, , United Kingdom
Countries
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Other Identifiers
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MO18660
Identifier Type: -
Identifier Source: org_study_id