A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
NCT ID: NCT01183858
Last Updated: 2015-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
315 participants
INTERVENTIONAL
2010-10-31
2014-02-28
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
DOUBLE
Study Groups
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Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Erlotinib [Tarceva]
Single daily oral dose
Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Erlotinib [Tarceva]
Single daily oral dose
Interventions
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Erlotinib [Tarceva]
Single daily oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
* Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥12 weeks
* Current cigarette smoker (having smoked \>100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study
Exclusion Criteria
* Radiotherapy within 28 days prior to enrollment
* Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
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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Beijing, , China
Changchun, , China
Chengdu, , China
Fuzhou, , China
Guangzhou, , China
Nanjing, , China
Nanning, , China
Shanghai, , China
Shanghai, , China
Shenyang, , China
Tianjin, , China
Wuhan, , China
Copenhagen, , Denmark
Hillerød, , Denmark
Næstved, , Denmark
Roskilde, , Denmark
Cairo, , Egypt
Cairo, , Egypt
Caen, , France
Limoges, , France
Marseille, , France
Paris, , France
Paris, , France
Paris, , France
Pontoise, , France
Berlin, , Germany
Berlin, , Germany
Essen, , Germany
Gauting, , Germany
Großhansdorf, , Germany
Hanover, , Germany
Hanover, , Germany
Immenhausen, , Germany
Lostau, , Germany
München, , Germany
Nuremberg, , Germany
Rheine, , Germany
Villingen-Schwenningen, , Germany
Wuppertal, , Germany
Würselen, , Germany
Amsterdam, , Netherlands
Breda, , Netherlands
Nieuwegein, , Netherlands
Zwolle, , Netherlands
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Baden, , Switzerland
Basel, , Switzerland
Bern, , Switzerland
Fribourg, , Switzerland
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Eskişehir, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Countries
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Other Identifiers
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2010-018476-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO22162
Identifier Type: -
Identifier Source: org_study_id
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