Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Kontakt
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or Kontakt: Phone: 1-317-615-4559 E-Mail: ClinicalTrials.gov@lilly.com» Kontaktdaten anzeigen
Phone: 49401818865008» Ansprechpartner anzeigenUCLA Hematology/Oncology - Santa Monica 90404 Los Angeles United StatesRekrutierend» Google-MapsStockton Hematology Oncology Group 95204 Stockton United StatesRekrutierend» Google-MapsLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 90502 Torrance United StatesRekrutierend» Google-MapsGenesisCare 33180 Aventura United StatesRekrutierend» Google-MapsGenesisCare - Boca Raton 33431 Boca Raton United StatesAbgeschlossen» Google-MapsMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-MapsMayo Clinic in Rochester, Minnesota 55905 Rochester United StatesRekrutierend» Google-MapsUSO - New York Oncology Hematology, P.C. 12206 Albany United StatesRekrutierend» Google-MapsUSO-New York Oncology Hematology, P.C 12065 Clifton Park United StatesRekrutierend» Google-Maps Ansprechpartner:
Phone: 518-262-6696» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center 10065 New York United StatesRekrutierend» Google-MapsSarah Cannon Research Institute SCRI 37203 Nashville United StatesRekrutierend» Google-MapsSarah Cannon Research Institute SCRI 37203 Nashville United StatesRekrutierend» Google-MapsTennessee Oncology Nashville 37203 Nashville United StatesRekrutierend» Google-MapsUSO - Texas Oncology - Austin 78705 Austin United StatesRekrutierend» Google-Maps Ansprechpartner:
Phone: 281-863-1000» Ansprechpartner anzeigenBorder Medical Oncology 2640 Albury AustraliaRekrutierend» Google-MapsSunshine Coast University Hospital 4575 Birtinya AustraliaRekrutierend» Google-MapsRockhampton Hospital 4700 Rockhampton AustraliaRekrutierend» Google-MapsThe Townsville Hospital 4814 Townsville AustraliaRekrutierend» Google-MapsBallarat Health Services 3350 Ballarat Central AustraliaRekrutierend» Google-MapsBendigo Health Care Group 3550 Bendigo AustraliaRekrutierend» Google-MapsGoulburn Valley Health 3630 Shepparton AustraliaRekrutierend» Google-MapsSouth West Healthcare 3280 Warrnambool AustraliaRekrutierend» Google-MapsLandeskrankenhaus Feldkirch 6800 Feldkirch AustriaRekrutierend» Google-MapsKlinik Floridsdorf 1210 Wien AustriaRekrutierend» Google-MapsAntwerp University Hospital 2650 Edegem BelgiumRekrutierend» Google-MapsCliniques universitaires Saint-Luc 1200 Brussels BelgiumRekrutierend» Google-MapsUniversité Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne 5530 Yvoir BelgiumRekrutierend» Google-MapsClinique Saint Pierre 1340 Ottignies BelgiumRekrutierend» Google-MapsAZ Delta vzw 8800 Roeselare BelgiumRekrutierend» Google-MapsCHU UCL Namur/Site Sainte Elisabeth 5000 Namur BelgiumRekrutierend» Google-Maps Ansprechpartner:
Phone: 003281720761» Ansprechpartner anzeigenNucleo de Oncologia da Bahia 40170-070 Salvador BrazilRekrutierend» Google-MapsSirio-Libanes Brasilia - Centro de Oncologia - Asa Sul 70200-730 Brasilia BrazilNoch nicht rekrutierend» Google-MapsCentro Avançado de Tratamento Oncológico- CENANTRON 30130090 Belo Horizonte BrazilRekrutierend» Google-MapsCentro Oncológico do Triângulo 38408-150 Uberlândia BrazilRekrutierend» Google-MapsHospital de Câncer de Recife 50040-000 Recife BrazilRekrutierend» Google-MapsHospital São Lucas da PUCRS 90610-000 Porto Alegre BrazilRekrutierend» Google-MapsHospital BP 01321-001 Sao Paulo BrazilNoch nicht rekrutierend» Google-Maps Ansprechpartner:
Phone: +5511985883170» Ansprechpartner anzeigenInstituto D'Or de Pesquisa e Ensino (IDOR) 04543-000 Sao Paulo BrazilRekrutierend» Google-Maps Ansprechpartner:
Phone: 551138932632» Ansprechpartner anzeigenSociedade Beneficente Israelita Brasileira Hospital Albert Einstein 05652-900 Sao Paulo BrazilNoch nicht rekrutierend» Google-MapsInstituto de Educação, Pesquisa e Gestão em Saúde 22775001 Rio de Janeiro BrazilRekrutierend» Google-MapsCentro Paulista de Oncologia Clínica 01452-000 São Paulo BrazilRekrutierend» Google-MapsNúcleo de Pesquisa Clínica da Rede São Camilo 04014-002 São Paulo BrazilRekrutierend» Google-MapsPrincess Margaret Cancer Centre M5G 2M9 Toronto CanadaRekrutierend» Google-MapsBeijing Friendship Hospital 100050 Beijing ChinaRekrutierend» Google-Maps Ansprechpartner:
Phone: 13910761058» Ansprechpartner anzeigenBeijing Cancer hospital 100142 Haidian District ChinaRekrutierend» Google-MapsFujian Provincial Hospital 350001 Fuzhou ChinaRekrutierend» Google-MapsSouthern Medical University Nanfang Hospital 510515 Guangzhou ChinaRekrutierend» Google-MapsGuangdong Provincial People's Hospital Guangzhou ChinaRekrutierend» Google-MapsHarbin Medical University Cancer Hospital 150081 Harbin ChinaRekrutierend» Google-MapsTongji Medical College of Huazhong University of Science and Technology 430022 Wuhan ChinaRekrutierend» Google-Maps Ansprechpartner:
Phone: 027-85726114» Ansprechpartner anzeigenXiangya Hospital, Central South University 410008 Changsha ChinaRekrutierend» Google-MapsHunan Cancer Hospital 410013 Changsha ChinaRekrutierend» Google-MapsHunan Cancer Hospital 410013 Changsha ChinaRekrutierend» Google-Maps Ansprechpartner:
Phone: 13170419973» Ansprechpartner anzeigenJilin Cancer Hospital 130000 Changchun ChinaRekrutierend» Google-MapsTangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army 710038 Xi'an ChinaRekrutierend» Google-MapsJinan Central Hospital 250013 Jinan ChinaRekrutierend» Google-Maps Ansprechpartner:
Phone: 2602165115006» Ansprechpartner anzeigenthe Third People's Hospital of Chengdu 610031 Chengdu ChinaRekrutierend» Google-MapsWest China Hospital of Sichuan University 610041 Chengdu ChinaRekrutierend» Google-MapsFirst Affiliated Hosp of College of Med, Zhejiang University 310003 Hangzhou ChinaRekrutierend» Google-MapsZhejiang Cancer Hospital Hangzhou ChinaRekrutierend» Google-Maps Ansprechpartner:
Phone: 3858182310» Ansprechpartner anzeigenMasarykuv onkologicky ustav 656 53 Brno CzechiaRekrutierend» Google-MapsNemocnice AGEL Ostrava - Vitkovice a.s 703 84 Ostrava CzechiaRekrutierend» Google-MapsFakultni nemocnice Bulovka 180 81 Prague CzechiaRekrutierend» Google-MapsOdense Universitetshospital 5000 Odense DenmarkRekrutierend» Google-MapsAssistance Publique Hôpitaux de Marseille - Hôpital de la Timone 13385 Marseille FranceRekrutierend» Google-MapsCHU Charles Nicolle 76031 Rouen FranceRekrutierend» Google-MapsCentre Chirurgical Marie Lannelongue 92350 Le Plessis-Robinson FranceRekrutierend» Google-MapsCentre Leon Berard 69373 Lyon CEDEX 08 FranceRekrutierend» Google-MapsHospices Civils de Lyon - Hopital Louis Pradel 69677 Lyon FranceRekrutierend» Google-MapsHopitaux Universitaires Paris Centre-Hopital Cochin 75014 Paris FranceRekrutierend» Google-MapsUniversity Hospital of Patras 26504 Patras GreeceRekrutierend» Google-MapsAgios Savvas Regional Cancer Hospital 115 22 Athens GreeceRekrutierend» Google-MapsErrikos Dunant Hospital Center 115 26 Athens GreeceRekrutierend» Google-MapsSotiria Thoracic Diseases Hospital of Athens 11527 Athens GreeceRekrutierend» Google-MapsUniversity General Hospital of Heraklion 711 10 Heraklion GreeceRekrutierend» Google-MapsEuropean Interbalkan Medical Center 570 01 Thessaloniki GreeceRekrutierend» Google-Maps Ansprechpartner:
Phone: 302310400368» Ansprechpartner anzeigenG. Papanikolaou General Hospital 570 10 Thessaloniki GreeceRekrutierend» Google-MapsHong Kong United Oncology Centre 000000 Hong Kong Hong KongRekrutierend» Google-MapsPrincess Margaret Hospital 999077 Lai Chi Kok Hong KongRekrutierend» Google-MapsQueen Elizabeth Hospital Yau Ma Tei Hong KongRekrutierend» Google-MapsRajiv Gandhi Cancer Institute And Research Centre 110085 New Delhi IndiaRekrutierend» Google-MapsRegional Cancer Centre - Thiruvananthapuram 695011 Thiruvananthapuram IndiaRekrutierend» Google-MapsTata Memorial Hospital 400012 Mumbai IndiaRekrutierend» Google-MapsRashtrasant Tukdoji Regional Cancer Hospital 440027 Nagpur IndiaRekrutierend» Google-MapsHCG Manavata Cancer Centre 422001 Nashik IndiaRekrutierend» Google-MapsSheba Medical Center 5265601 Ramat Gan IsraelRekrutierend» Google-MapsHadassah Medical Center 9112001 Jerusalem IsraelRekrutierend» Google-MapsRambam Health Care Campus 3109601 Haifa IsraelRekrutierend» Google-MapsASST Grande Ospedale Metropolitano Niguarda 20162 Milan ItalyRekrutierend» Google-MapsHumanitas 20089 Rozzano ItalyRekrutierend» Google-MapsAzienda Ospedaliera Dei Colli 80131 Naples ItalyRekrutierend» Google-MapsInstituto Tumori Giovanni Paolo II 70124 Bari ItalyRekrutierend» Google-MapsAzienda Sanitaria Ospedaliera S Luigi Gonzaga 10043 Orbassano ItalyRekrutierend» Google-MapsIstituto Oncologico Veneto IRCCS 35128 Padova ItalyRekrutierend» Google-MapsAichi Cancer Center Hospital 464-8681 Nagoya JapanRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Kashiwa JapanRekrutierend» Google-MapsNiigata Cancer Center Hospital 951-8566 Niigata JapanRekrutierend» Google-MapsHimeji Medical Center 670-8520 Himeji JapanRekrutierend» Google-MapsHikita Pediatric clinic 241-8515 Yokohama JapanRekrutierend» Google-MapsTominaga Hospital 411-8777 Nagaizumi JapanRekrutierend» Google-MapsJapanese Foundation for Cancer Research 135-8550 Koto JapanRekrutierend» Google-Maps Ansprechpartner:
Phone: 81120023812» Ansprechpartner anzeigenTottori University Hospital 683-8504 Yonago JapanRekrutierend» Google-MapsHiroshima University Hospital 734-8551 Hiroshima JapanRekrutierend» Google-MapsOsaka Medical Center for Cancer and Cardiovascular Diseases 541-8567 Osaka JapanRekrutierend» Google-MapsChonnam National University Hwasun Hospital 58128 Hwasun Korea, Republic ofRekrutierend» Google-MapsNational Cancer Center 10408 Goyang-si Korea, Republic ofRekrutierend» Google-MapsSeoul National University Bundang Hospital 13620 Seongnam Korea, Republic ofRekrutierend» Google-MapsPusan National University Hospital 49241 Busan Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 3080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System 3722 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 5505 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 6351 Seoul Korea, Republic ofRekrutierend» Google-MapsKorea University Guro Hospital 8308 Seoul Korea, Republic ofRekrutierend» Google-MapsKyungpook National University Chilgok Hospital 41404 Deagu Korea, Republic ofRekrutierend» Google-MapsActualidad Basada en la Investigación del Cáncer 44680 Guadalajara MexicoAbgeschlossen» Google-MapsOncare Viaducto Napoles 03810 Cdmx MexicoAbgeschlossen» Google-MapsAvix Investigación Clinica, S.C. 64710 Monterrey MexicoAbgeschlossen» Google-MapsHospital Universitario ""Dr. Jose Eleuterio Gonzalez" 66460 Monterrey MexicoAbgeschlossen» Google-MapsZiekenhuis St. Jansdal 3844 DG Harderwijk NetherlandsRekrutierend» Google-MapsRadboudumc 6500HB Nijmegen NetherlandsRekrutierend» Google-MapsOslo Universitetssykehus Ullevål 0450 Oslo NorwayRekrutierend» Google-MapsNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie 02-781 Warszawa PolandRekrutierend» Google-MapsUniwersyteckie Centrum Kliniczne 80-952 Gdańsk PolandRekrutierend» Google-MapsWielkopolskie Centrum Pulmonologii i Torakochirurgii 60-569 Poznan PolandRekrutierend» Google-MapsPan American Center for Oncology Trials 00935 Rio Piedras Puerto RicoRekrutierend» Google-MapsInstitutul Oncologic 400015 Cluj RomaniaRekrutierend» Google-MapsArkhangelsk Clinical Oncological Dispensary 163045 Arkhangelsk Russian FederationAbgeschlossen» Google-MapsHadassah Medical 121205 Moscow Russian FederationRekrutierend» Google-MapsFirst Pavlov State Medical University of Saint Petersburg 197022 Saint Petersburg Russian FederationAbgeschlossen» Google-MapsScientific research institution of oncology named after N.N. Petrov 197758 Sankt-Peterburg Russian FederationAbgeschlossen» Google-MapsParkway Cancer Centre - Gleneagles Hospital 258500 Singapore SingaporeRekrutierend» Google-MapsTan Tock Seng Hospital 308433 Singapore SingaporeRekrutierend» Google-MapsCHUS - Hospital Clinico Universitario 15706 Santiago de Compostela SpainRekrutierend» Google-MapsHospital Universitario Reina Sofia 14004 Cordoba SpainRekrutierend» Google-MapsHospital Universitario Puerta del Mar 11009 Cádiz SpainRekrutierend» Google-MapsHospital Universitario Central de Asturias 33011 Oviedo SpainRekrutierend» Google-MapsInstitut Català d'Oncologia (ICO) - Badalona 08916 Badalona SpainRekrutierend» Google-MapsParc de Salut Mar - Hospital del Mar 8003 Barcelona SpainRekrutierend» Google-MapsHospital Universitari Vall d'Hebron 8035 Barcelona SpainRekrutierend» Google-MapsInstituto Catalan de Oncologia - Hospital Duran i Reynals 8907 L'Hospitalet Del Llobregat SpainRekrutierend» Google-MapsHospital de Mataró" 8304 Mataró SpainRekrutierend» Google-MapsComplejo Asistencial Universitario de León - Hospital de León 24071 León SpainRekrutierend» Google-MapsHospital Universitari Dexeusa 8028 Barcelona SpainRekrutierend» Google-MapsHospital Clínic de Barcelona 8036 Barcelona SpainRekrutierend» Google-MapsHospital Son Llàtzer 7198 Palma SpainRekrutierend» Google-MapsHospital Lucus Augusti 27003 Lugo SpainRekrutierend» Google-MapsHospital Universitario Ramón y Cajal 28034 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHospital Clínico Universitario Virgen de la Arrixaca 30120 El Palmar, Murcia SpainRekrutierend» Google-MapsComplexo Hospitalario Universitario de Ourense 32005 Ourense SpainRekrutierend» Google-MapsCHUVI- Hospital Alvaro Cunqueiro 36312 Pontevedra SpainRekrutierend» Google-MapsHospital Universitario de Canarias 38320 La Laguna SpainRekrutierend» Google-MapsHospital Universitari Sant Joan de Reus 43204 Reus SpainRekrutierend» Google-MapsHospital General Universitario de Albacete 2006 Albacete SpainRekrutierend» Google-MapsMD Anderson Cancer Center 28033 Madrid SpainRekrutierend» Google-MapsHospital Clinico San Carlos 28040 Madrid SpainRekrutierend» Google-MapsHospital Regional Universitario 29011 Málaga SpainRekrutierend» Google-MapsHospital Universitario Virgen Macarena 41009 Sevilla SpainRekrutierend» Google-MapsHospital Universitari i Politecnic La Fe 46026 València SpainRekrutierend» Google-MapsSahlgrenska Universitetssjukhuset 413 45 Gothenburg SwedenRekrutierend» Google-MapsChanghua Christian Hospital 50006 Changhua County TaiwanRekrutierend» Google-MapsChang Gung Memorial Hospital at Kaohsiung 83301 Kaohsiung Niao Sung Dist TaiwanRekrutierend» Google-MapsChung Shan Medical University Hospital 402 Taichung City TaiwanRekrutierend» Google-MapsChi Mei Hospital - Liouying Branch 73657 Tainan City TaiwanRekrutierend» Google-MapsNational Taiwan University Cancer Center (NTUCC) 106 Taipei City TaiwanRekrutierend» Google-MapsTaipei Veterans General Hospital 112 Taipei City TaiwanRekrutierend» Google-MapsKaohsiung Medical University Chung-Ho Memorial Hospital 80756 Kaohsiung TaiwanRekrutierend» Google-MapsTaichung Veterans General Hospital 40705 Taichung TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital 10002 Taipei TaiwanRekrutierend» Google-MapsChang Gung Medical Foundation-Linkou Branch 333 Taoyuan TaiwanRekrutierend» Google-MapsBaskent University Dr. Turgut Noyan Research and Training Center 1250 Adana TurkeyRekrutierend» Google-MapsEge Universitesi Hastanesi 35100 Bornova TurkeyRekrutierend» Google-MapsIzmir Medical Park Hospital 009035575 Izmir, Karsiyaka TurkeyRekrutierend» Google-MapsAdana City Hospital 1370 Adana TurkeyRekrutierend» Google-MapsDr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma 6200 Ankara TurkeyRekrutierend» Google-MapsAnkara City Hospital 6800 Ankara TurkeyRekrutierend» Google-MapsMemorial Antalya Hospital 7090 Antalya TurkeyRekrutierend» Google-MapsUludag Universitesi 16059 Bursa TurkeyRekrutierend» Google-MapsDicle Üniversitesi 21100 Diyarbakir TurkeyRekrutierend» Google-MapsTrakya University 22030 Edirne TurkeyRekrutierend» Google-Maps Ansprechpartner:
Phone: 905322480988» Ansprechpartner anzeigenMedipol Mega Universite Hastanesi 34214 Istanbul TurkeyRekrutierend» Google-MapsAcıbadem Maslak Hastanesi 34457 İstanbul TurkeyRekrutierend» Google-MapsIzmir Katip Celebi Universitesi Ataturk Egitim Ve Arastrma Hastanesi 35620 Izmir TurkeyRekrutierend» Google-Mapsİnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma 44280 Malatya TurkeyRekrutierend» Google-MapsSumy regional clinical oncological dispensary 40022 Sumy UkraineRekrutierend» Google-MapsChelsea and Westminster Hospital NHS Foundation Trust SW10 9NH London United KingdomRekrutierend» Google-MapsRoyal Brompton Hospital SW3 6NP London United KingdomRekrutierend» Google-MapsUniversity College London Hospital NW1 2PG London United KingdomRekrutierend» Google-MapsCity Hospital, Nottingham University Hospitals NG5 1PB Nottingham United KingdomRekrutierend» Google-MapsNew Cross Hospital WV10 0QP Wolverhampton United KingdomRekrutierend» Google-Maps
1. Event-Free Survival (EFS) (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)): EFS by Investigator Assessment in the Primary Analysis Population
Secondary outcome:
1. EFS (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)): EFS by investigator assessment in the overall population
2. Overall Survival (OS) (Time Frame - Randomization to death from any cause (estimated as up to 9 years)]): OS
3. EFS (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]): EFS by blinded independent central review (BICR)
4. Time to Distant Disease Recurrence in the Central Nervous System (CNS) (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)): Time to distant disease recurrence in the CNS by investigator assessment and BICR
5. Progression Free Survival on the Next Line of Treatment (PFS2) (Time Frame - Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)): PFS2 by investigator assessment
6. Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test (Time Frame - Baseline): PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
7. Mean Change from Baseline over Time in NSCLC Symptoms (Time Frame - Baseline to treatment discontinuation (estimated as up to 3 years)): NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.
8. Mean Change from Baseline over Time in Physical Function (Time Frame - Baseline to treatment discontinuation (estimated as up to 3 years)): Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.