Spots Global Cancer Trial Database for Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
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Trial Identification
Brief Title: Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
Official Title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib
Study ID: NCT02604342
Conditions
Study Description
Brief Summary: This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GHdC Site Notre Dame, Charleroi, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
MBAL Serdika EOOD, Sofia, , Bulgaria
Centre Francois Baclesse, Caen, , France
Hopital Bichat Claude Bernard ; Service de Pneumologie, Paris, , France
Hopital Du Haut Leveque; Service Des Maladies Respiratoires, Pessac, , France
Hopital Foch; Pneumologie, Suresnes, , France
Hopital Sainte Musse; Pneumologie, Toulon, , France
Hopital Larrey; Pneumologie, Toulouse, , France
Hopital Robert Schuman; Pneumologie, Vantoux, , France
Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie, Bad Berka, , Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie, Berlin, , Germany
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie, Gauting, , Germany
Fachklinik für Lungenerkrankungen, Immenhausen, , Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie, Oldenburg, , Germany
Queen Elizabeth Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, , Hong Kong
Semmelweis Egyetem X; Pulmonologiai Klinika, Budapest, , Hungary
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati, Avellino, Campania, Italy
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico, Napoli, Campania, Italy
Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare, Napoli, Campania, Italy
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica, Ravenna, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1, Roma, Lazio, Italy
Irccs Ospedale San Raffaele;Oncologia Medica, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milano, Lombardia, Italy
POLICLINICO RODOLICO, U.O. di Oncologia Medica, Catania, Sicilia, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii, Pisa, Toscana, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Perugia, Umbria, Italy
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Korea University Guro Hospital; Oncology, Seoul, , Korea, Republic of
Oslo Universitetssykehus HF; Radiumhospitalet, Oslo, , Norway
Medical University of Gdansk, Gdansk, , Poland
Hospital Geral; Servico de Pneumologia, Coimbra, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
CHVNG/E_Unidade 1; Servico de Pneumologia, Vila Nova De Gaia, , Portugal
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF, St Petersburg, Leningrad, Russian Federation
University сlinic of headaches, Moscow, Moskovskaja Oblast, Russian Federation
Main Military Clinical Hospital named after N.N. Burdenko, Moscow, , Russian Federation
City Clinical Oncology Hospital, Moscow, , Russian Federation
City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint-Petersburg, , Russian Federation
FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU, Banska Bystrica, , Slovakia
Vychodoslovensky onkologicky ustav, Košice, , Slovakia
Hospital Universitario de Torrejon, Torrejon de Ardoz, Madrid, Spain
Hospital de Cruces; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Adana Acıbadem Hospital Oncology Department, Adana, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Ankara, , Turkey
Istanbul Uni Capa Medical Faculty; Inst. of Oncology, Istanbul, , Turkey
Ege University Medical Faculty; Chest Diseases, Izmir, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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