BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
NCT ID: NCT00949650
Last Updated: 2018-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
345 participants
INTERVENTIONAL
2009-08-14
2017-03-16
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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BIBW 2992
BIBW 2992 tablet once daily until progression
BIBW 2992
BIBW 2992 once daily until progression
Cisplatin/Pemetrexed
Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
Pemetrexed
Pemetrexed IV given once every 3 weeks for up to 6 cycles
Cisplatin
Cisplatin IV given once every 3 weeks for up to 6 cycles
Interventions
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Pemetrexed
Pemetrexed IV given once every 3 weeks for up to 6 cycles
BIBW 2992
BIBW 2992 once daily until progression
Cisplatin
Cisplatin IV given once every 3 weeks for up to 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
* Measurable disease according to RECIST 1.1.
* Eastern Cooperative Oncology Group score of 0 or 1.
* Age \>/= 18 years.
* Life expectancy of at least three months.
* Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.
Exclusion Criteria
* Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
* Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
* Active brain metastases
* Any other current malignancy or malignancy diagnosed within the past five years
* Known pre-existing interstitial lung disease.
* Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
* History or presence of clinically relevant cardiovascular abnormalities.
* Any other concomitant serious illness or organ system dysfunction.
* Adequate absolute neutrophil count and platelet count
* Adequate liver and kidney function
* Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Medical Radiology Science Centre
Obninsk, , Russia
First Pavlov State Medical University Saint Petersburg
Saint Petersburg, , Russia
Highlands Oncology Group
Fayetteville, Arkansas, United States
Clinical Trials and Research Associates Inc
Montebello, California, United States
Innovative Medical Research of South Florida
Miami, Florida, United States
Crescent City Research Consortiom
Marrero, Louisiana, United States
Interlakes Foundation, Incorporated
Rochester, New York, United States
Lehigh Valley Hospital / Lehigh Valley Health Network
Allentown, Pennsylvania, United States
South Texas Institute of Cancer, Northwest Cancer Center
Corpus Christi, Texas, United States
Instituto de Medicina Nuclear de Bahía Blanca
Bahía Blanca, , Argentina
Hospital Alemán
Capital Federal, , Argentina
Imcaba S.R.L.
Capital Federal, , Argentina
IMAI Research
Capital Federal, , Argentina
Instituto Alexander Fleming
Capital Federal, , Argentina
Hospital Militar Central
Capital Federal, , Argentina
PALIAR
Capital Federal, , Argentina
Centro Oncológico de Rosario
Rosario, , Argentina
Lifehouse
Camperdown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Burnside War Memorial Hospital
Toorak Gardens, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
St. Vincents Hospital (MEL)
Fitzroy, Victoria, Australia
Mount Medical Centre
Perth, Western Australia, Australia
KH d. Elisabethinen Linz
Linz, , Austria
SMZ Baumgartner Hoehe Otto Wagner Spital
Vienna, , Austria
Klinikum Wels - Grieskirchen GmbH
Wels, , Austria
Brussels - UNIV St-Pierre
Brussels, , Belgium
UNIV UZ Gent
Ghent, , Belgium
Brussels - UNIV UZ Brussel
Jette, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Centro de Pesquisa do Hospital Lifecenter
Belo Horizonte, , Brazil
Centro de Pesquisas Clínicas em Oncología
Cachoeiro de Itapemirim, , Brazil
Insituto de Oncologia do Paraná
Curitiba, , Brazil
Hospital São Lucas da Pontifícia Universidade Católica
Porto Alegre, , Brazil
UNIFESP Departamento de Medicina de Pneumologia
São Paulo, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada
Charles LeMoyne Hospital
Greenfield Park, Migration Data, Canada
Hematologiste et oncologue medical CHUM - Hopital Notre-Dame
Montreal, Migration Data, Canada
McGill University, Department of Oncology
Montreal, Migration Data, Canada
Hospital Dirección de Previsión de Carabineros
Los Condes, , Chile
Instituto Oncológico Limitada Viña del Mar
Reñaca, , Chile
Instituto Clínico Oncológico del Sur - ICOS
Temuco, , Chile
HOP d'Angers
Angers, , France
HOP Côte de Nacre
Caen, , France
HOP Nord Michallon
La Tronche, , France
HOP Croix Rousse, Pneumo, Lyon
Lyon, , France
INS Curie
Paris, , France
HOP Sud-Réunion, Pneumo, Saint Pierre
Saint Pierre - La Réunion, , France
CTR René Gauducheau
Saint-Herblain, , France
HOP - HIA Sainte Anne
Toulon, , France
HOP, Pneumo, Villefranche sur Saône
Villefranche-sur-Saône, , France
Universitätsklinikum Benjamin Franklin, Berlin
Berlin, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Lungenklinik Hemer
Hemer, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Münster
Münster, , Germany
Pius-Hospital, Oldenburg
Oldenburg, , Germany
National Taiwan University Hospital
Taipei, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Szent György Hospital, Szekesfehervar
Székesfehérvár, , Hungary
Markusovszky County Hospital, Szombathely
Szombathely, , Hungary
Zala County Hospital, Zalaegerszeg
Zalaegerszeg, , Hungary
St James's Hospital
Dublin, , Ireland
Ospedale San Donato di Arezzo
Arezzo, , Italy
Az. USL 4 di Prato
Prato, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
Osp. Silvestrin
Sant'Andrea Delle Fratte (PG), , Italy
National Hospital Organization Nagoya Medical Center
Aichi, Nagoya, , Japan
Aichi Cancer Center Hospital
Aichi, Nagoya, , Japan
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Matsuyama, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, Sapporo, , Japan
Institute of Biomedical Research and Innovation Hospital
Hyogo, Kobe, , Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Niigata Cancer Center Hospital
Niigata, Niigata, , Japan
Kurashiki Central Hospital
Okayama, Kurashiki, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Kindai University Hospital
Osaka, Osaka-Sayama, , Japan
Osaka City Hospital Organization Osaka City General Hospital
Osaka, Osaka, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Osaka, , Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, , Japan
Hospital Pulau Pinang
Palau Pinang, , Malaysia
Pusat Perubatan University Kebangsaan Malaysia
Wilayah Persekutuan, , Malaysia
University Malaya Medical Centre
Wilayah Persekutuan, , Malaysia
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria, , Peru
Clínica Anglo Americana
San Isidro, , Peru
Instituto Nacional de Enfermedades Neoplásicas
Surquillo, , Peru
Perpetual Succour Hospital (Cebu)
Cebu City, , Philippines
Makati Medical Center
Makati City, , Philippines
St. Luke Medical Centre
Quezon, , Philippines
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, , Romania
ONCOLAB SRL, Craiova
Craiova, , Romania
Republic Clinical Oncology Dispensary, Dept. Chemotherapy
Kazan', , Russia
FSBSI "N.N Blokhin Medical Research Center of Oncology"
Moscow, , Russia
SPb SBIH "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
Saint Petersburg, , Russia
Chungbuk National University Hospital
Cheongju-si, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
NCKUH
Tainan City, , Taiwan
Taipe Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan District, , Taiwan
Ramathibodi Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Srinagarind Hospital
Khonkaen, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
City Clinical Hospital #4, Dnipropetrovsk State Medical Academy
Dnipropetrovsk, , Ukraine
Donetsk Regional Antitumor Centre
Donetsk, , Ukraine
Kharkiv Regional Clinical Oncology Center
Kharkiv, , Ukraine
Lviv State Oncological Regional Treatment & Diagnostic CTR
Lviv, , Ukraine
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Maidstone Hospital, Kent Oncology Centre
Maidstone, , United Kingdom
Scunthorpe General Hospital, Oncology
Scunthorpe, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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References
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Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations. J Clin Oncol. 2023 Jun 1;41(16):2869-2876. doi: 10.1200/JCO.22.02547.
Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.
Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Marten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. doi: 10.1093/annonc/mdw322. Epub 2016 Sep 6.
Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.
Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.
Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.
Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.
Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.
Other Identifiers
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2008-005615-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.32
Identifier Type: -
Identifier Source: org_study_id
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