Spots Global Cancer Trial Database for A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title: A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study ID: NCT03735121
Conditions
Study Description
Brief Summary: This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Consultorio Dr. Miguel Angel Escudero, Salta, , Argentina
INCA 1- Instituto Nacional de Câncer X, Rio de Janeiro, RJ, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Bradford Hill Centro de Investigaciones Clinicas, Recoleta, , Chile
James Lind Centro de Investigación Del Cáncer, Temuco, , Chile
ONCOCENTRO APYS; Oncología, Vina Del Mar, , Chile
Beijing Cancer Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
West China Hospital - Sichuan University, Chengdu City, , China
Cancer Center of Guangzhou Medical University, Guangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou City, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Jinan Central Hospital, Jinan City, , China
Tianjin Cancer Hospital, Tianjin, , China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
Clinica CIMCA, San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas, San José, , Costa Rica
Aphm; Cpcet, Marseille, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
General Hospital "G.Papanikolaou"; Pulmonogy Clinic, Asvestochori, , Greece
Sotiria Hospital, Athens, , Greece
INTEGRA Cancer Institute, Ciudad de Guatemala, , Guatemala
Hospital El Pilar, Ciudad de Guatemala, , Guatemala
Grupo Angeles, Guatemala City, , Guatemala
Oncomedica, Guatemala, , Guatemala
Matrai Gyogyintezet, Matrahaza, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár, , Hungary
Református Pulmonológiai Centrum; Oncology Department, Törökbálint, , Hungary
Asst Papa Giovanni XXIII; Oncologia Medica, Bergamo, Lombardia, Italy
IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI), Lombardia, Italy
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Centre; Medical Oncology, Seoul, , Korea, Republic of
Riga East Clinical University Hospital Latvian Oncology Centre, Riga, , Latvia
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Cuidados oncologicos, Querétaro, Queretaro, Mexico
Auckland City Hospital, Cancer and Blood Research, Auckland, , New Zealand
Christchurch Clinical Studies Trust Ltd, Christchurch, , New Zealand
Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre, Hamilton, , New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School, Tauranga, , New Zealand
Centro Medico Monte Carmelo, Arequipa, , Peru
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel, Lima, , Peru
Oncosalud Sac; Oncología, Lima, , Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional, Lima, , Peru
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej, Grudzi?dz, , Poland
Centrum Terapii Wspolczesnej, Lodz, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology, Otwock, , Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz, Warszawa, , Poland
Mordovia State University, Saransk, Mordovija, Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, Moskovskaja Oblast, Russian Federation
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF, Moscow, Moskovskaja Oblast, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy, Moscow, Moskovskaja Oblast, Russian Federation
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod, Nizhny Novgorod, Niznij Novgorod, Russian Federation
SBIH Kaluga Region Clinical Oncology Dispensary, Kaluga, , Russian Federation
Murmansk Regional Clinical Hospital named after P.A. Bayandin, Murmansk, , Russian Federation
Multidisciplinary clinic Reaviz, Samara, , Russian Federation
Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept, Cape Town, , South Africa
Richards Bay Oncology Centre, KwaZulu Natal, , South Africa
Wilgers Oncology Centre, Pretoria, , South Africa
Sandton Oncology Medical Group, Sandton, , South Africa
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Vajira Hospital, Bangkok, , Thailand
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Prapokklao Hospital, Chanthaburi, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine, ChiangMai, , Thailand
Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine, Hat Yai, , Thailand
Khonkaen Hospital, Khonkaen, , Thailand
Udonthani Cancer Hospital, Udonthani, Muang,Udonthani, , Thailand
Ankara Bilkent City Hospital, Ankara, , Turkey
Medipol University Medical Faculty; Oncology Department, Istanbul, , Turkey
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department, Istanbul, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Municipal Institution City Clinical Hospital #4 of Dnipro City Council, Dnipropetrovsk, Katerynoslav Governorate, Ukraine
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs, Kharkiv, Kharkiv Governorate, Ukraine
Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
St James Hospital; Dept of Oncology/Hematology, Leeds, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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