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Brief Title: A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
Official Title: A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of Tobemstomig Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study ID: NCT05775289
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mitchell Cancer Institute; Pharmacy, Mobile, Alabama, United States
Henry Ford Health System; Hematology/Oncology, Detroit, Michigan, United States
Renown Regional Medical Center Hospital, Reno, Nevada, United States
Cooper Health System; MD Anderson Cancer Center, Camden, New Jersey, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Virginia Commonwealth University Medical Center Main Hospital, Richmond, Virginia, United States
Westmead Hospital, Westmead, New South Wales, Australia
Pindara Private Hospital, Benowa, Queensland, Australia
Lyell McEwin Hospital, Adelaide, South Australia, Australia
Monash Health, Clayton, Victoria, Australia
Barwon Health, Geelong, Victoria, Australia
UZ Brussel, Brussel, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
AZ St Maarten Campus Leopoldstr, Mechelen, , Belgium
Nucleo de Oncologia da Bahia - NOB, Salvador, Bahia, BA, Brazil
Crio - Centro Regional Integrado de Oncologia, Fortaleza, CE, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital de Clínicas de Porto Alegre X, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Windsor Regional Hospital, Windsor, Ontario, Canada
Hopital Jean Minjoz; Pneumologie, Besancon, , France
Centre Leon Berard, Lyon, , France
Hopital Cochin; Unite Fonctionnelle D Oncologie, Paris, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
Centre Paul Strauss; Oncologie Medicale, Strasbourg, , France
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique, Toulouse cedex 9, , France
Uniklinik Essen, Essen, , Germany
LungenClinic Großhansdorf GmbH; Klinische Forschung, Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Lungenfachklinik Immenhausen, Immenhausen, , Germany
Azienda Ospedaliera San Giuseppe Moscati, Avellino, Campania, Italy
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica, Bologna, Emilia-Romagna, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica, Roma, Lazio, Italy
IRCCS AOU San Martino - IST, Genova, Liguria, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia, Milano, Lombardia, Italy
Asst Di Monza, Monza, Lombardia, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
ONCARE Viaducto Napoles, Ciudad de México, Mexico CITY (federal District), Mexico
AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V, Ciudad de México, Mexico CITY (federal District), Mexico
Instituto Nacional de Cancerologia; Oncology, Mexico City, , Mexico
Oncológico Potosino, San Luis Potosí, , Mexico
Institut Catala d Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital Son Llatzer, Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
Memorial Ankara Hastanesi, Ankara, , Turkey
Ankara City Hospital; Oncology, Ankara, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Medipol University Medical Faculty; Oncology Department, Istanbul, , Turkey
?zmir Medical Park; Onkoloji, Izmir, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-LaRoche
Role: STUDY_DIRECTOR