Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
NCT ID: NCT00148798
Last Updated: 2014-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1861 participants
INTERVENTIONAL
2004-10-31
2012-05-31
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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Cetuximab plus chemotherapy
cetuximab + cisplatin + vinorelbine
cetuximab + cisplatin + vinorelbine
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Chemotherapy alone
cisplatin + vinorelbine alone
cisplatin + vinorelbine
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Interventions
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cetuximab + cisplatin + vinorelbine
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
cisplatin + vinorelbine
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Eligibility Criteria
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Inclusion Criteria
* Immunohistochemical evidence of EGFR expression on tumor tissue
* Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area
Exclusion Criteria
* Previous chemotherapy for NSCLC
* Documented or symptomatic brain metastasis
* Superior vena cava syndrome contra-indicating hydration
* Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Pirker, Professor
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik für Innere Medizin I, Wien
Locations
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Research Site
Buenos Aires, , Argentina
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Córdoba, , Argentina
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Adelaide, , Australia
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Melbourne, , Australia
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Randwick, , Australia
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Sydney, , Australia
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Wodonga, , Australia
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Vienna, , Austria
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Brussels, , Belgium
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Charleroi, , Belgium
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Liège, , Belgium
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Antofagasta, , Chile
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Santiago, , Chile
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Brno, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Brest, , France
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Caen, , France
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Grenoble, , France
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Marseille, , France
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Paris, , France
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Poitiers, , France
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Rennes, , France
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Rouen, , France
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Strasbourg, , France
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Augsburg, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Göttingen, , Germany
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Großhansdorf, , Germany
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Halle-Dölau, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Löwenstein, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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München, , Germany
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Stralsund, , Germany
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Wuppertal, , Germany
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Honh Kong, , Hong Kong
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Budapest, , Hungary
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Nyiregyháza, , Hungary
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Székesfehérvár, , Hungary
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Szombathely, , Hungary
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Törökbálint, , Hungary
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Zalegerzeg-Pózva, , Hungary
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Dublin, , Ireland
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Bologna, , Italy
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Carpi, , Italy
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Milan, , Italy
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Rome, , Italy
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Rozzano-Milano, , Italy
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Treviglio, , Italy
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Mexico City, , Mexico
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Monterrey, , Mexico
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Amsterdam, , Netherlands
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Nieuwegeln, , Netherlands
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Zwolle, , Netherlands
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Bydgoszcz, , Poland
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Olsztyn, , Poland
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Otwock, , Poland
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Posnan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Nitra-Zobor, , Slovakia
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Poprad, , Slovakia
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Seoul, , South Korea
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Barakaldo (Bilbao), , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Elche Alicante, , Spain
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Granollers, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Pontevedra, , Spain
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Santander, , Spain
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Terrassa, , Spain
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Valencia, , Spain
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Stockholm, , Sweden
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Uppsala, , Sweden
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Bern, , Switzerland
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Thun, , Switzerland
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Zurich, , Switzerland
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Taipei, Tao Yuan County, Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Dnipropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Poltava, , Ukraine
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Sumy, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Aberdeen, , United Kingdom
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Bristol, , United Kingdom
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Edinburgh, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Poole, , United Kingdom
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Sutton, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.
Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Eberhardt WE, de Marinis F, Heeger S, Goddemeier T, O'Byrne KJ, Gatzemeier U. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer. 2012 Aug;77(2):376-82. doi: 10.1016/j.lungcan.2012.03.010. Epub 2012 Apr 11.
Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. doi: 10.1016/S1470-2045(11)70318-7. Epub 2011 Nov 4.
O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795-805. doi: 10.1016/S1470-2045(11)70189-9. Epub 2011 Jul 22.
Gatzemeier U, von Pawel J, Vynnychenko I, Zatloukal P, de Marinis F, Eberhardt WE, Paz-Ares L, Schumacher KM, Goddemeier T, O'Byrne KJ, Pirker R. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol. 2011 Jan;12(1):30-7. doi: 10.1016/S1470-2045(10)70278-3. Epub 2010 Dec 17.
Other Identifiers
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EMR 62202-046
Identifier Type: -
Identifier Source: org_study_id
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