check_circleStudy Completed
Carcinoma, Non-Small-Cell Lung
Bayer Identifier:
13266
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A 3rd/4th line placebo-controlled trial of sorafenib in patients with predominantly non squamous Non-Small Cell Lung Cancer (NSCLC).
Trial purpose
The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
703Trial Dates
April 2009 - April 2013Phase
Phase 3Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Krankenhaus Grosshansdorf | Großhansdorf, 22927, Germany |
Completed | Asklepios Fachkliniken München Gauting | Gauting, 82131, Germany |
Terminated | Asklepios Klinik Harburg | Hamburg, 21075, Germany |
Completed | St. Vincentius-Kliniken gAG | Karlsruhe, 76137, Germany |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Completed | Aberdeen Royal Infirmary | Aberdeen, AB25 2ZN, United Kingdom |
Completed | Addenbrookes Hospital | Cambridge, CB2 0QQ, United Kingdom |
Completed | Southmead Hospital | Bristol, BS10 5NB, United Kingdom |
Completed | Highlands Oncology Group | Fayetteville, 72703, United States |
Completed | Centre Georges Francois Leclerc Dijon | DIJON, 21000, France |
Completed | Hôpital de la Croix Rousse | LYON CEDEX, 69317, France |
Completed | Hôpital Bretonneau - Tours | TOURS, 37044, France |
Completed | Kliniken der Stadt Köln - Städt. Krankenhaus Köln-Merheim | Köln, 51109, Germany |
Completed | Thoraxklinik-Heidelberg gGmbH | Heidelberg, 69126, Germany |
Completed | St James' University Hospital | Leeds, LS9 7TF, United Kingdom |
Completed | Royal Free Hospital | London, NW3 2QG, United Kingdom |
Completed | Christie Hospital | Greater Manchester, M20 4BX, United Kingdom |
Completed | Stanford Hospital & Clinics | Stanford, 94305, United States |
Completed | Centre René Gauducheau - Nantes | SAINT HERBLAIN, 44805, France |
Completed | Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego | Szczecin, 70-891, Poland |
Terminated | Szpital Miejski sw. Aleksandra | Kielce, 25-316, Poland |
Completed | Kinki University Hospital | Osakasayama, 589-8511, Japan |
Completed | Kinki-Chuo Chest Medical Center | Sakai, 591-8555, Japan |
Completed | National Cancer Center Hospital East | Kashiwa, 277-8577, Japan |
Completed | A.O. San Camillo-Forlanini | Roma, 00151, Italy |
Completed | A.O.U. di Perugia | Perugia, 06156, Italy |
Completed | A.O. San Gerardo di Monza | Monza, 20052, Italy |
Completed | Centre Oscar Lambret | Lille, 59020, France |
Completed | Center Hospitalier Michallon - Grenoble | LA TRONCHE, 38700, France |
Completed | Centre François Baclesse - CLCC - Caen | CAEN, 14073, France |
Completed | Centrum Onkologii Instytut im. M. Sklodowskiej-Curie | Krakow, 31-115, Poland |
Completed | Instytut Gruzlicy i Chorob Pluc | Warszawa, 01-138, Poland |
Completed | NZOZ MRUKMED 2 Sp. p., Przychodnia Specjalistyczna | Rzeszow, 35-021, Poland |
Completed | Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc | Olsztyn, 10-357, Poland |
Completed | Teikyo University Hospital | Itabashi-ku, 173-8606, Japan |
Completed | The Cancer Institute Hospital of JFCR | Koto-ku, 135-8550, Japan |
Completed | Hyogo Cancer Center | Akashi, 673-8558, Japan |
Completed | National Kyushu Cancer Center | Fukuoka, 811-1395, Japan |
Completed | Aichi Cancer Center Hospital | Nagoya, 464-8681, Japan |
Completed | IRCCS Istituto Clinico Humanitas | Rozzano, 20089, Italy |
Completed | A.O.U. di Parma | Parma, 43100, Italy |
Completed | AUSL 06 Livorno - Toscana | Livorno, 57124, Italy |
Completed | A.O.U. San Luigi Gonzaga | Orbassano, 10043, Italy |
Completed | A.O. San Giuseppe Moscati | Avellino, 83100, Italy |
Completed | Hospital Regional Carlos Haya | Málaga, 29010, Spain |
Completed | Complejo Hospitalario de Zamora | Zamora, 49021, Spain |
Completed | Hospital de Cruces | Cruces/Barakaldo, 48903, Spain |
Completed | Hospital de la Santa Creu i de Sant Pau | Barcelona, 08025, Spain |
Completed | Hospital Universitario Arnau de Vilanova de Lleida | Lleida, 25198, Spain |
Completed | Hopsital Lucus Agustí | Lugo, 27003, Spain |
Completed | Isala Klinieken, Locatie Sophia | ZWOLLE, 8025 AB, Netherlands |
Completed | Skånes Universitetssjukhus | Lund, 221 85, Sweden |
Completed | Karolinska Universitetssjukhuset i Solna | Stockholm, 171 76, Sweden |
Completed | Falu Lasarett | Falun, 791 82, Sweden |
Completed | Langehoven Drive Oncology Centre | Port Elizabeth, 6045, South Africa |
Completed | Dr Pirjol, Szpak 7 Moodley | Durban, 4126, South Africa |
Completed | Meir Medical Center | Kfar Saba, 4428164, Israel |
Completed | Assaf Harofeh Medical Center | Zrifin, 6093000, Israel |
Completed | Shaare Zedek Medical Center | Jerusalem, 9372212, Israel |
Completed | IRCCS Ist Nazionale Tumori GE | Genova, 16132, Italy |
Completed | Hospital Universitario Virgen del Rocío | Sevilla, 41013, Spain |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Terminated | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Complejo Hospitalario de Orense | Orense, 32005, Spain |
Completed | McGill University | Montreal, H2W 1S6, Canada |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | Ziekenhuis Oost-Limburg | GENK, 3600, Belgium |
Terminated | ZNA Middelheim | ANTWERPEN, 2020, Belgium |
Completed | Grand Hôpital de Charleroi | CHARLEROI, 6000, Belgium |
Completed | St. Antonius Ziekenhuis | NIEUWEGEIN, 3435 CM, Netherlands |
Completed | Vrije Universiteit Medisch Centrum | Amsterdam, 1081HV, Netherlands |
Completed | Atrium Medisch Centrum Parkstad | HEERLEN, 6419 PC, Netherlands |
Completed | Ziekenhuis St. Jansdal | HARDERWIJK, 3844 DG, Netherlands |
Completed | Elkerliek Ziekenhuis, Lokatie Helmond | HELMOND, 5707 HA, Netherlands |
Completed | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | District Dispensary for Oncology Diseases with Inpatient | Plovdiv, Bulgaria |
Completed | Interdistrict Dispensary for Oncological Diseases Dr.M.Marko | Varna, 9002, Bulgaria |
Completed | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Terminated | Consultorios Médicos Privados | Ramos Mejía, B1704ESN, Argentina |
Terminated | Hospital Privado de Córdoba | Córdoba, X5016KEH, Argentina |
Completed | Krankenhaus der Elisabethinen Linz | Linz, 4010, Austria |
Completed | Pest County Lung Institute | Torokbalint, 2045, Hungary |
Completed | Zala Megyei Korhaz | Zalaegerszeg, 8900, Hungary |
Completed | Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest, 1529, Hungary |
Completed | Hospital e Maternidade Brasil | Santo André, 09020 110, Brazil |
Completed | Hospital Israelita Albert Einstein | São Paulo, 05651-900, Brazil |
Completed | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90050 170, Brazil |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, 413 45, Sweden |
Completed | Universitetssjukhuset i Linköping | Linköping, 581 85, Sweden |
Completed | University of Pretoria, Prinshof Campus | Prietoria, 0084, South Africa |
Terminated | Medcial Oncology Centre Rosebank | Johannesburg, 2196, South Africa |
Terminated | Panorama GVI Oncology | Cape Town, 7500, South Africa |
Completed | Edith Wolfson Medical Center | Holon, Israel |
Completed | Rabin Medical Center - Beilinson Campus | Petach Tikva, 4941492, Israel |
Completed | District Dispensary for Oncology Diseases with Inpatient | Sofia, 1784, Bulgaria |
Completed | Specialized Hospital for Active Treatment of Oncology | Sofia, Bulgaria |
Terminated | Centro Especializado ISIS | Santa Fé, S3000FFV, Argentina |
Terminated | Centro Oncológico de Rosario | Rosario, S2000DSK, Argentina |
Terminated | Instituto Oncológico Dr. J. M. Urrutia | Córdoba, 5000, Argentina |
Terminated | Instituto C.A.I.C.I. | Rosario, 2000, Argentina |
Terminated | PALIAR | Buenos Aires, C1430ERF, Argentina |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Instituto de Oncologia do Vale | São José dos Campos, 12245750, Brazil |
Completed | Clinical Oncology Dispensary | Kazan, 420029, Russia |
Terminated | Clinical Oncology Hospital | Yaroslavl, 150054, Russia |
Completed | Shanghai Pulmonary Hospital, Tongji University | Shanghai, 200433, China |
Completed | Chinese PLA General Hosp. | Beijing, 100853, China |
Completed | Sir Run Run Shaw Hospital | Hangzhou, 310016, China |
Completed | National Cancer Center DHARMAIS | Jakarta, 11420, Indonesia |
Completed | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Seoul St. Mary's Hospital | Seoul, 137-701, Korea, Republic Of |
Completed | National Taiwan University Hospital | Taipei, 10016, Taiwan |
Completed | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Completed | Kaohsiung Medical University Hospital | Kaohsiung, 80756, Taiwan |
Completed | Hospital Edgardo Rebagliati Martins | Lima, LIMA 11, Peru |
Completed | Hospital Nacional Guillermo Almenara Irigoyen | Lima, LIMA 1, Peru |
Terminated | Princess Margaret Hospital | Kowloon, Hong Kong |
Terminated | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | Instituto Nacional del Cancer | Santiago, 838-0455, Chile |
Completed | Hospital Clínico Universidad de Chile | Santiago, 838-0456, Chile |
Completed | Veszprem County Pulmonology Institute | Farkasgyepu, 8582, Hungary |
Completed | Ege Universitesi Tip Fakultesi | Izmir, Turkey |
Completed | Marmara University Medical Faculty | INSTANBUL, 34662, Turkey |
Completed | Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul, Turkey |
Completed | Anadolu Saglik Merkezi | Kocaeli, 41400, Turkey |
Completed | Ankara Universitesi Tip Fakultesi | Ankara, Turkey |
Completed | University General Hospital of Heraklion | Heraklion, 711 10, Greece |
Completed | Sotiria General State Hospital of Chest Diseases | Athens, 11527, Greece |
Completed | G. Papanikolaou General Hospital of Thessaloniki | Thessaloniki, 570 10, Greece |
Completed | Grupo de Assistencia Medica e Prestacao de Servicos Ltda | Sao Paulo, 01224-010, Brazil |
Completed | Veterans Memorial Medical Center | Quezon City, 1104, Philippines |
Completed | Perpetual Succour Hospital | Cebu City, 6000, Philippines |
Completed | Manila Doctors Hospital | Metro Manila, 1000, Philippines |
Completed | National University Cancer Institute, Singapore | Singapore, 119228, Singapore |
Completed | Johns Hopkins Singapore IMC | Singapore, 308433, Singapore |
Completed | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai, 50200, Thailand |
Completed | Mayo Hospital | Lahore, 54000, Pakistan |
Completed | BioCancer | Belo Horizonte, 30150-281, Brazil |
Completed | Hospital Sao Lucas da Pontificia Universidade Catolica do RS | Porto Alegre, 90610-000, Brazil |
Terminated | Centro Especializado en Oncología y Hematología Brasilia | Brasilia, 70680-650, Brazil |
Completed | Railways Hospital named after Semashko | Moscow, 129128, Russia |
Completed | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Completed | City Clinical Oncology Center | St. Petersburg, 198255, Russia |
Terminated | Moscow Clinical Oncology Dispensary n. 1 | Moscow, 105 005, Russia |
Completed | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Completed | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing, 100021, China |
Completed | Guangdong General Hospital | Guangzhou, 510080, China |
Completed | Sun Yat-sen University Cancer Center | Guangzhou, 510060, China |
Completed | Shanghai Chest Hospital, Shanghai Jiaotong University | Shanghai, 200030, China |
Completed | PLA 81 Hospital | Nanjing, 210002, China |
Completed | Peking University Cancer Hospital | Beijing, 100142, China |
Completed | 307 Hospital of PLA | Beijing, 100071, China |
Completed | Zhejiang Cancer Hospital | Hangzhou, 310022, China |
Completed | West China Hospital, Sichuan University | Chengdu, 610041, China |
Terminated | Hasan Sadikin Hospital | Bandung, 40161, Indonesia |
Completed | Korea University Anam Hospital | Seoul, 136-705, Korea, Republic Of |
Completed | Seoul National University Hospital | Seoul, 110-744, Korea, Republic Of |
Completed | Samsung Medical Center | Seoul, 135-710, Korea, Republic Of |
Completed | Curie Manavata Cancer Centre | Mumbai, 422004, India |
Completed | Lakeshore Hospital and Research Center Ltd | Kerala, 682304, India |
Completed | Ruby Hall Clinic | Pune, 411001, India |
Completed | Chang Gung Memorial Hospital at Linkou | Taoyuan, 333, Taiwan |
Completed | China Medical University Hospital | Taichung, 404, Taiwan |
Terminated | Clínica El Golf | Lima, LIMA 27, Peru |
Completed | Hospital Alberto Sabogal Sologuren | Callao, CALLAO 2, Peru |
Terminated | Oncosalud | San Borja, Peru |
Completed | Prince of Wales Hospital | Shatin, Hong Kong |
Completed | Queen Mary Hospital | Hongkong, Hong Kong |
Completed | Santo Tomás University Hospital | Manila, 1000, Philippines |
Completed | Siriraj Hospital, Mahidol | Bangkok, 10700, Thailand |
Completed | Prince of Songkla University | Songkhla, 90110, Thailand |
Completed | Dr Ziauddin Hospital | Karachi, 74700, Pakistan |
Completed | Centre Hospitalier Départemental-La Roche sur Yon | LA ROCHE SUR YON CEDEX, 85025, France |
Completed | Koch Robert Hospital | Edeleny, 3780, Hungary |
Completed | University of Semmelweis | Budapest, 1125, Hungary |
Terminated | Rittenhouse Hematology/Oncology | Philadelphia, 19107, United States |
Completed | Zentralklinik Bad Berka GmbH | Bad Berka, 99437, Germany |
Terminated | Klinikum Innenstadt der Ludwigs-Maximilians-Universität | München, 80336, Germany |
Terminated | Klinikum Mannheim gGmbH | Mannheim, 68167, Germany |
Terminated | Klinikum Kassel GmbH | Kassel, 34125, Germany |
Completed | Universitätsklinikum Ulm | Ulm, 89091, Germany |
Terminated | Instituto Nacional de Enfermedades Neoplásicas | Lima, LIMA 34, Peru |
Primary Outcome
- Overall survivaldate_rangeTime Frame:From randomization of the first subject until 36 months laterenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Progression-free survivaldate_rangeTime Frame:From randomization of the first subject until 36 months later assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Disease controldate_rangeTime Frame:From randomization of the first subject until 36 months later assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Objective tumor responsedate_rangeTime Frame:From randomization of the first subject until 36 months later assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Time to progressiondate_rangeTime Frame:From randomization of the first subject until 36 months later assessed every 6 weeksenhanced_encryptionNoSafety Issue:
- Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health statusdate_rangeTime Frame:Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)enhanced_encryptionNoSafety Issue:
- Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13) - coughing subscaledate_rangeTime Frame:Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)enhanced_encryptionNoSafety Issue:
- Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13) - dyspneadate_rangeTime Frame:Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)enhanced_encryptionNoSafety Issue:
- Mean change from baseline in EuroQol-5D (EQ-5D) - index scoredate_rangeTime Frame:Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)enhanced_encryptionNoSafety Issue:
- Mean change from baseline in EuroQol-5D (EQ-5D) - VAS scoredate_rangeTime Frame:Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2