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Brief Title: Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy
Official Title: A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy
Study ID: NCT04471428
Brief Summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
Kaiser Permanente - San Diego, San Diego, California, United States
Sansum Clinic, Santa Barbara, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Regional Cancer Care Associates, Bethesda, Maryland, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Minnesota Oncology Hematology, Saint Paul, Minnesota, United States
Consultants in Medical Oncology and Hematology, Broomall, Pennsylvania, United States
Charleston Oncology, P .A, Charleston, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Huntsman Cancer Institute at The University of Utah, Salt Lake City, Utah, United States
Virginia Cancer Specialists (Fairfax) - USOR, Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg, Roanoke, Virginia, United States
Royal North Shore Hospital; Oncology, St. Leonards, New South Wales, Australia
Townsville Hospital, Townsville, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Austin Hospital Olivia Newton John Cancer Centre, Heidelberg, Victoria, Australia
Affinity Oncology, Nedlands, Western Australia, Australia
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie, Graz, , Austria
Ordensklinikum Linz Elisabethinen, Linz, , Austria
Lhk Feldkirch; Interne Medizin Abt., Rankweil, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Wien, , Austria
Institut Jules Bordet, Anderlecht, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Clinique de l'Europe, Amiens, , France
CHU Angers,Service de Pneumologie, Angers, , France
CHU de Grenoble, Grenoble, , France
Hopital Dupuytren; Pneumologie, Limoges, , France
Hôpital Saint Joseph; Oncologie Medicale, Marseille, , France
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie, Montpellier, , France
Centre Hospitalier de Mulhouse - Hopital Emile Muller, Mulhouse, , France
Hopital Tenon;Pneumologie, Paris, , France
Zentralklinik Bad Berka GmbH; Pneumologie, Bad Berka, , Germany
KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie, Essen, , Germany
Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V, Gießen, , Germany
KRH Klinikum Siloah-Oststadt-Heidehaus, Hannover, , Germany
Klinikum Koeln-Merheim; Lungenklinik, Köln, , Germany
Universitaetsklinikum Giessen und Marburg, Marburg, , Germany
Brüderkrankenhaus St. Josef Paderborn, Paderborn, , Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine, Athens, , Greece
Henri Dunant Hospital; Oncology Dept., Athens, , Greece
Uoa Sotiria Hospital; Oncology, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico, Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria di Parma, Parma, Emilia-Romagna, Italy
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica, Ravenna, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO), Aviano, Friuli-Venezia Giulia, Italy
Policlinico Umberto I, Oncologia B, Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
IRCCS AOU San Martino - IST, Genova, Liguria, Italy
ASST Spedali Civili di Brescia, Brescia, Lombardia, Italy
Instituto Europeo di Oncologia, Milano, Lombardia, Italy
Istituto Clinico Humanitas, Rozzano (MI), Lombardia, Italy
Ospedale Vito Fazzi, Lecce, Puglia, Italy
A.O.U Careggi, Florence, Toscana, Italy
Hyogo Cancer Center, Hyogo, , Japan
Sendai Kousei Hospital, Miyagi, , Japan
Osaka International Cancer Institute, Osaka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Chungbuk National University Hospital, Cheongju si, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
St. Vincent's Hospital, Gyeonggi-do, , Korea, Republic of
Ajou University Medical Center, Gyeonggi-do, , Korea, Republic of
Samsung Changwon Hospital, Gyeongsangnam-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii, Bydgoszcz, , Poland
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej, Bytom, , Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter., Gliwice, , Poland
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii, Otwock, , Poland
Hospital Pulido Valente; Servico de Pneumologia, Lisboa, , Portugal
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia, Porto, , Portugal
Hospital CUF Porto; Servico Pneumologia, Porto, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
CHVNG/E_Unidade 1; Servico de Pneumologia, Vila Nova de Gaia, , Portugal
Regional Clinical Oncology Hospital, Yaroslavl, Jaroslavl, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy, Moscow, Moskovskaja Oblast, Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint-Petersburg, Sankt Petersburg, Russian Federation
GBUZ Leningradskaya state clinical hospital, St. Petersburg, Sankt Petersburg, Russian Federation
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia, Sevilla, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe; Oncologia, Valencia, , Spain
Addenbrookes Hospital, Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Huddersfield Royal Infirmary; The Learning Centre, Huddersfield, , United Kingdom
Barts & London School of Med; Medical Oncology, London, , United Kingdom
University College London Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Chelsea & Westminster Hospital, London, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR