A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00556712
Last Updated: 2015-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
889 participants
INTERVENTIONAL
2006-01-31
2010-11-30
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
Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity.
erlotinib [Tarceva]
150mg po daily
Placebo
Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.
Placebo
po daily
Interventions
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erlotinib [Tarceva]
150mg po daily
Placebo
po daily
Eligibility Criteria
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Inclusion Criteria
* histologically documented, locally advanced , recurrent or metastatic NSCLC;
* measurable disease;
* no disease progression after 4 cycles of platinum-based chemotherapy.
Exclusion Criteria
* any other malignancies in the last 5 years.
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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St Leonards, New South Wales, Australia
Waratah, New South Wales, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
East Bentleigh, Victoria, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Innsbruck, , Austria
Klagenfurt, , Austria
Vienna, , Austria
Vienna, , Austria
Antwerp, , Belgium
Edegem, , Belgium
Winnipeg, Manitoba, Canada
Oshawa, Ontario, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Beijing, , China
Guangzhou, , China
Guangzhou, , China
Shanghai, , China
České Budějovice, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Herlev, , Denmark
Odense, , Denmark
Bayonne, , France
Brest, , France
Clermont-Ferrand, , France
Dijon, , France
Le Mans, , France
Lille, , France
Limoges, , France
Paris, , France
Paris, , France
Pau, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Bad Berka, , Germany
Bochum, , Germany
Halle, , Germany
Herne, , Germany
Neuruppin, , Germany
Villingen-Schwenningen, , Germany
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Deszk, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szombathely, , Hungary
Törökbálint, , Hungary
Bologna, Emilia-Romagna, Italy
Rome, Lazio, Italy
Ancona, The Marches, Italy
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
George Town, , Malaysia
Kuala Lumpur, , Malaysia
Amsterdam, , Netherlands
Flushing, , Netherlands
Heerlen, , Netherlands
Nieuwegein, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Lodz, , Poland
Lodz, , Poland
Otwock, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Balashikha, , Russia
Chelyabinsk, , Russia
Kazan', , Russia
Kazan', , Russia
Kirov, , Russia
Krasnodar, , Russia
Krasnodar, , Russia
Kuzmolovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Perm, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Sashi, , Russia
Smolensk, , Russia
Yaroslavl, , Russia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Nitra, , Slovakia
Poprad, , Slovakia
Golnik, , Slovenia
Ljubljana, , Slovenia
Maribor, , Slovenia
Durban, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Santander, Cantabria, Spain
A Coruña, La Coruña, Spain
Oviedo, Principality of Asturias, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Kharkiv, , Ukraine
Uzhhorod, , Ukraine
Zaporizhzhya, , Ukraine
Chelmsford, , United Kingdom
Dundee, , United Kingdom
Leicester, , United Kingdom
Plymouth, , United Kingdom
Caracas, , Venezuela
Countries
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References
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Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.
Other Identifiers
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BO18192
Identifier Type: -
Identifier Source: org_study_id
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