Spots Global Cancer Trial Database for Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
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Trial Identification
Brief Title: Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
Official Title: A Multicenter, Randomized, Double-blind Phase III Trial to Evaluate Efficacy and Safety of BI 695502 Plus Chemotherapy Versus Avastin® Plus Chemotherapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
Study ID: NCT02272413
Conditions
Study Description
Brief Summary: The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate \[ORR\], proportion of patients with complete response \[CR\] plus partial response \[PR\]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Lalita Pandit, M.D., Inc., Fountain Valley, California, United States
Southern California Oncology Research Alliance, Los Angeles, California, United States
Innovative Clinical Research, Inc., Whittier, California, United States
Ashland Bellefonte Cancer Center, Ashland, Kentucky, United States
Reliant Medical Group, Worcester, Massachusetts, United States
Detroit Clinical Research Center, Owosso, Michigan, United States
Carolinas Cancer Care, Charlotte, North Carolina, United States
CENIT - Centro de Neurociencias, Investigacion y Tratamiento, Ciudad Autonoma Buenos Aires, , Argentina
Sanatorio Delta, Rosario, , Argentina
Sanatorio Parque, Rosario, , Argentina
Centro Oncológico de Rosario, Rosario, , Argentina
CPCO - Centro de Pesquisa Clinica em Oncologia, Cachoeiro de Itapemirim, , Brazil
Hospital do Cancer do Ceara, Fortaleza, , Brazil
Pronutrir, Fortaleza, , Brazil
Hospital de Carida de de Ijui - CACON, Ijuí, , Brazil
Hospital Bruno Born, Lajeado, , Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo, , Brazil
Universidade de Caxias do Sul - IPCEM - Inst. de Pesq.clilni, Petrópolis, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, , Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André, , Brazil
Clinica de Oncologia de Sorocaba, Sorocaba, , Brazil
ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho, São Paulo, , Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo, São Paulo, , Brazil
MHAT - Dobrich, AD, Dobrich, , Bulgaria
UMHAT Georgi Stranski, Clinic of Paediatrics, Pleven, Pleven, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD, Plovdiv, , Bulgaria
DCC 1 - Ruse, EOOD, Ruse, , Bulgaria
MHAT Serdika, EOOD, Sofia, Sofia, , Bulgaria
MHAT 'Tokuda Hospital Sofia', EAD, Sofia, , Bulgaria
SHATOD 'Dr. Marko Antonov Markov'-Varna, EOOD, Varna, , Bulgaria
Clínica Santa María, Santiago, , Chile
Hospital Clínico San Borja Arriarán, Santiago, , Chile
Centro Internacional de Estudios Clinicos - CIEC, Santiago, , Chile
Instituto Clínico Oncológico del Sur - ICOS, Temuco, , Chile
Hospital Clinico Viña del Mar, Viña del Mar, , Chile
General Hospital Pula, Pula, , Croatia
Clinical Hospital Centar Sestre Milosrdnice, Zagreb, , Croatia
University Clinic for Pulmonary Diseases, Zagreb, , Croatia
Alexandria University Hospital, Alexandria, , Egypt
Ain Shams University Hospital, Cairo, , Egypt
National Cancer Institute, Cairo University, Cairo, , Egypt
Nasser Institute, Cairo, , Egypt
Oncology Centre- Mansoura University, Mansoura, , Egypt
Menofiya University Hospital, Monofia, , Egypt
Gesundheitszentrum Wetterau gGmbH, Bad Nauheim, , Germany
Athens Hospital of Chest Diseases "Sotiria", Athens, , Greece
University General Hospital of Heraklion, Crete, , Greece
University of Patras Medical School, Patras, , Greece
Euromedica Kyanous Stavros General Hospital, Thessaloniki, , Greece
Health Center of Thermi, Thessaloniki, Thessaloniki, , Greece
Interbalkan Medical Center of Thessaloniki, Thessaloniki, , Greece
National Koranyi TBC and Pulm. Internal Med. Clinic, Budapest, , Hungary
Semmelweis University, Budapest, , Hungary
Pulmonology Institute of Veszprem County, Farkasgyepu, Farkasgyepu, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet, Szolnok, , Hungary
Markusovszky University Teaching Hospital, Szombathely, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
ASST di Cremona, Cremona, , Italy
Osp. Umberto I, Lugo (RA), , Italy
Istituto Scientifico Romagnolo, Meldola (FC), , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Aichi Medical University Hospital, Aichi, Nagakute, , Japan
Aichi Cancer Center Aichi Hospital, Aichi, Okazaki, , Japan
Tosei General Hospital, Aichi, Seto, , Japan
Fujita Health University Hospital, Aichi, Toyoake, , Japan
Aso Co.,Ltd Iizuka Hospital, Fukuoka, Iizuka, , Japan
Gunma Prefectural Cancer Center, Gunma, Ota, , Japan
Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Amagasaki, , Japan
Itami City Hospital, Hyogo, Itami, , Japan
Kobe City Medical Center General Hospital, Hyogo, Kobe, , Japan
Ibaraki Prefectural Central Hospital, Ibaraki, Kasama, , Japan
Kagawa Rosai Hospital, Kagawa, Marugame, , Japan
Kitasato University Hospital, Kanagawa, Sagamihara, , Japan
Yokohama City University Hospital, Kanagawa, Yokohama, , Japan
Uji-Tokushukai Medical Center, Kyoto, Uji, , Japan
Matsusaka City Hospital, Mie, Matsusaka, , Japan
Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Miyazaki, , Japan
Nara Hospital Kinki University Faculty of Medicine, Nara, Ikoma, , Japan
Niigata Cancer Center Hospital, Niigata, Niigata, , Japan
Kansai Medical University Hospital, Osaka, Hirakata, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Osaka, , Japan
Takatsuki Red Cross Hospital, Osaka, Takatsuki, , Japan
Saitama Medical University International Medical Center, Saitama, Hidaka, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai-shi, , Japan
Nippon Medical School Hospital, Tokyo, Bunkyo-ku, , Japan
Nihon University Itabashi Hospital, Tokyo, Itabashi-ku, , Japan
Japan Anti-Tuberculosis Association Fukujuji Hospital, Tokyo, Kiyose, , Japan
Toranomon Hospital, Tokyo, Minato-ku, , Japan
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, St.Vincent's Hospital, Suwon-si, , Korea, Republic of
Hospital Pulau Pinang, Georgetown Pulau Pinang, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan, Kuantan, , Malaysia
Investigacion Biomedica para el Desarrollo de Farmacos, El Salto, , Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C., Merida, , Mexico
Axis Heilsa S. de R.L. de C.V., Monterrey, Monterrey, , Mexico
Clinical Medical Research S.C, Orizaba, , Mexico
Hospital San Jose Querétaro, Queretaro, , Mexico
Centro Hemato Oncológico Privado, Toluca, , Mexico
Dr. Pablo O. Torre Memorial Hospital, Bacolod City, , Philippines
Cebu Doctors Hospital, Cebu City, , Philippines
Perpetual Succour Hospital (Cebu), Cebu City, , Philippines
Manila Doctors Hospital, Manila, , Philippines
Lung Center of the Philippines, Quezon City, , Philippines
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej, Jelenia Gora, , Poland
KO-MED Centra Kliniczne Lublin II, Lublin, , Poland
Zofia Tarnowska domo Zamoyska,RegHosp.Cardiol.Dep,Tarnobrzeg, Tarnobrzeg, , Poland
The Provincial Polyclinical Hospital in Torun, Torun, , Poland
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie, Warszawa, , Poland
Magodent Sp. Z o.o., Warszawa, , Poland
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra, , Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente, Lisboa, , Portugal
IPO Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião, Santa Maria da Feira, , Portugal
Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, , Portugal
Baia Mare Emergency County Hospital, Baia Mare, , Romania
Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu', Bucuresti, , Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca, Cluj Napoca, , Romania
Spitalul Militar de Urgenta Dr.Papilian, Cluj-Napoca, Cluj-Napoca, , Romania
S.C Oncocenter Oncologie Clinica S.R.L, Timisoara, , Romania
SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary", Arkhangelsk, , Russian Federation
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan", Kazan, , Russian Federation
RBIH "Kursk regional clinical oncology dispensary", Kursk, , Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF, Moscow, , Russian Federation
BHI of Omsk region - Clinical Oncology Dispensary, Omsk, , Russian Federation
SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary", Pyatigorsk, , Russian Federation
GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg, St. Petersburg, , Russian Federation
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst., St. Petersburg, , Russian Federation
SPb SBIH "City Clinical Oncological Dispensary", St. Petersburg, , Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF, St. Petersburg, , Russian Federation
Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco., Belgrade, , Serbia
Clinical Center Bezanijska kosa, Belgrade, Belgrade, , Serbia
Clinic of Pulmonary Diseases and Tuberculosis 'Knez Selo', Gornji Matejevac, , Serbia
Clinical Center Kragujevac, Kragujevac, , Serbia
Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol, Sremska Kamenica, , Serbia
GVI Cape Gate Oncology Centre, Cape Town, , South Africa
Rondebosch Oncology Centre, Cape town, , South Africa
GVI Oncology Outeniqua Unit, George, , South Africa
West Rand Oncology Centre, Johannesburg, Johannesburg, , South Africa
Langenhoven Drive Oncology Centre, Port Elizabeth, , South Africa
Hospital Infanta Cristina, Badajoz, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Clínico de Santiago, Santiago de Compostela, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Hospital Nuestra Señora de Valme, Sevilla, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Songklanagarind Hospital, Hat Yai, , Thailand
Ubonratchathani Cancer Hospital, Muang, Muang, , Thailand
Udonthani Cancer Hospital, Muang, Muang, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Muang, , Thailand
Lampang Hospital, Muang, , Thailand
Naresuan University Hospital, Muang, , Thailand
Akdeniz University Medical Faculty, Antalya, , Turkey
Inonu Uni. Med. Fac., Battalgazi, Battalgazi, , Turkey
Dicle University Medical Faculty, Diyarbakir, , Turkey
Trakya Universitesi Tip Fakultesi, Edirne, , Turkey
Gaziantep University, Gaziantep, , Turkey
Bezmi Alem Foundation University Medical Faculty Hospital, Istanbul, , Turkey
Yeditepe University Medical School Hospital, Istanbul, , Turkey
Fatih University Faculty of Medicince, Istanbul, Istanbul, , Turkey
CTPI Chernihiv Regional Oncological Dispensary, Chernihiv, Chernihiv, , Ukraine
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council, Dnipropetrovsk, , Ukraine
CHI Kharkiv Regional Clinical Oncological Center, Kharkiv, , Ukraine
Kherson Regional Oncologic Dispensary, Kherson, Kherson, , Ukraine
Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad, Kirovohrad, , Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC, Kryvyi Rih, Dnipropetrovsk, , Ukraine
National Institute of Cancer, Kyiv, , Ukraine
Medical and Preventive Treatment Inst. Volyn Regional, Lutsk, Lutsk, , Ukraine
CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent., Lviv, , Ukraine
Poltava Regional Clinical Oncological Dispensary, Poltava, Poltava, , Ukraine
Sumy Regional Oncology Center, Sumy, , Ukraine
CI of TRC Ternopil RC Oncological Dispensary Thoracic Dept, Ternopil, , Ukraine
Uzhgorod National University, Oncology Centre, Uzhgorod, , Ukraine
Transcarpathian Reg Clin Oncological Dispensary, Uzhgorod, Uzhgorod, , Ukraine
Vinnytsia Regional Clinical Oncological Dispensary, Vinnytsia, , Ukraine
CI Zapor Reg Cl Oncological Dispensary of ZRC, Zhaporizhzhia, Zhaporizhzhia, , Ukraine
Cheltenham General Hospital, Cheltenham, , United Kingdom
Wythenshawe Hospital, Manchester, , United Kingdom
Can Tho Oncology Hospital, Can Tho, , Vietnam
Bach Mai hospital, Hanoi, , Vietnam
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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