A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
研究单位:[1]Hoffmann-La Roche[2]Hospital Sao Rafael - HSR,Salvador,BA,Brazil,41253-190[3]Oncoclinicas Rio de Janeiro S.A.,Rio de Janeiro,RJ,Brazil,22250-905[4]Hospital de Cancer de Barretos,Barretos,SP,Brazil,14784-400[5]Instituto do Cancer do Estado de Sao Paulo - ICESP,Sao Paulo,SP,Brazil,01246-000[6]Beijing Union Hospital,Beijing,China,100730[7]Jilin Cancer Hospital,Changchun,China,132013[8]Hunan Cancer Hospital,Changsha CITY,China,410013[9]The Second Xiangya Hospital of Central South University,Changsha,China,410011[10]Sichuan Provincial Cancer Hospital,Chengdu,China,610041[11]West China Hospital, Sichuan University,Chengdu,China,610041[12]The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,China,510120[13]Harbin Medical University Cancer Hospital,Harbin,China,150081[14]Affiliated Hospital of Jining Medical University,Jining,China,272029[15]Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School,Nanjing City,China,210008[16]Guangxi Cancer Hospital of Guangxi Medical University,Nanning,China,530021[17]Shanghai Pulmonary Hospital,Shanghai,China,200433[18]Taihe Hospital of Hubei University of Medicine,Shiyan,China,442000[19]Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan City,China,430023[20]Clinical Hospital Centre Zagreb,Zagreb,Croatia,10000[21]Institut Bergonie[22]Pneumology,Bordeaux,France,33076[23]CHRU Lille,Lille,France,59037[24]Centre Leon Berard,Lyon,France,69008[25]Hopital Nord AP-HM,Marseille,France,13015[26]CHU Rennes - Hopital Pontchaillou,Rennes cedex 09,France,35033[27]Hopital Larrey[28]Pneumologie,Toulouse,France,31059[29]Hopital Robert Schuman[30]Pneumologie,Vantoux,France,57070[31]Uoa Sotiria Hospital[32]Oncology,Athens,Greece,115 27[33]Metropolitan Hospital,Athens,Greece,185 47[34]University Hospital of Larissa[35]Department of Medical Oncology,Larissa,Greece,411 10[36]Euromedical General Clinic of Thessaloniki[37]Oncology Department,Thessaloniki,Greece,546 45[38]American Oncology Institute,Hyderabad,Andhra Pradesh,India,500019[39]All India Institute Of Medical Sciences (AIIMS),New Delhi,Delhi,India,110029[40]MVR Cancer Centre and Research Institute,Kozhikode,Kerala,India,673601[41]Mumbai Oncocare Centre,Mumbai,Maharashtra,India,400036[42]Mumbai Oncocare Center[43]Medical Oncology,Mumbai,Maharashtra,India,400056[44]Christian Medical College,Ranipet,Tamil NADU,India,632513[45]Tata Medical Center[46]Department of Medical Oncology,Kolkata,WEST Bengal,India,700160[47]Postgraduate Institute of Medical Education and Research,Chandigarh,India,160012[48]Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale,Napoli,Campania,Italy,80131[49]IRCCS Istituto Regina Elena (IFO)[50]Oncologia Medica B,Roma,Lazio,Italy,00144[51]Azienda Ospedaliera San Camillo Forlanini[52]U.O.C. Pneumologia Ad Indirizzo Oncologico 1,Roma,Lazio,Italy,00152[53]IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)[54]Oncologia Medica A,Genova,Liguria,Italy,16132[55]Irccs Istituto Europeo di Oncologia (IEO)[56]Divisione di Oncologia,Milano,Lombardia,Italy,20141[57]Asst Grande Ospedale Metropolitano Niguarda[58]Dipartimento Di Ematologia Ed Oncologia,Milano,Lombardia,Italy,20162[59]ASST DI MONZA[60]Oncologia Medica,Monza,Lombardia,Italy,20900[61]Azienda Sanitaria Ospedaliera S Luigi Gonzaga[62]SSD Oncologia Polomonare (II PAD. IV PIANO),Orbassano,Piemonte,Italy,10043[63]Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello[64]Dipartimento Cardio Toraco Vascolare,Pisa,Toscana,Italy,56124[65]IRCCS Istituto Oncologico Veneto (IOV)[66]Oncologia Medica Seconda,Padova,Veneto,Italy,35128[67]King Hussein Cancer Center,Amman,Jordan,11941[68]Hotel Dieu de France,Beirut,Lebanon[69]Hospital Civil de Guadalajara Fray Antonio Alcalde,Guadalajara,Jalis
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.