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Активно (без набиране) Фаза 3 NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

Фаза 3 – широко изпитване преди одобрение
Заболявания: Non-Small Cell Lung Cancer KRAS G12C Lung Cancer

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
Кой може да участва
Inclusion Criteria: * Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation * Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Documentation of the presence of a KRAS G12C mutation * Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of \>= 12 weeks Exclusion Criteria: * Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib * Malabsorption syndrome or other condition that would interfere with enteral absorption * Known concomitant second oncogenic driver * Mixed small-cell lung cancer or large cell neuroendocrine histology * Known and untreated, or active central nervous system (CNS) metastases * Leptomeningeal disease or carcinomatous meningitis * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently * Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1 * Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor * More than 30 Gy of radiotherapy to the lung within 6 months of randomization * Uncontrolled tumor-related pain * Unresolved toxicities from prior anticancer therapy * History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Интервенции
Divarasib
DRUG
Sotorasib
DRUG
Adagrasib
DRUG
Места на провеждане 151
Argentina (2)
Hospital Britanico
Buenos Aires
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires
Австралия (5)
Sunshine Coast University Hospital
Birtinya , Queensland
Lyell McEwin Hospital
Elizabeth Vale , South Australia
Liverpool Hospital
Liverpool , New South Wales
Peter Maccallum Cancer Centre
Melbourne , Victoria
GenesisCare North Shore
St Leonards , New South Wales
Австрия (1)
Krankenhaus Nord - Klinik Floridsdorf
Vienna
Белгия (10)
AZORG Campus Aalst-Moorselbaan
Aalst
UZ Brussel
Brussels
Cliniques Universitaires St-Luc
Brussels
UZ Antwerpen
Edegem
Jessa Zkh (Campus Virga Jesse)
Hasselt
CHU de Liège (Sart Tilman)
Liège
CHU UCL Mont-Godinne
Mont-godinne
AZ Delta (Campus Rumbeke)
Roeselare
Vitaz
Sint-Niklaas
ZAS Sint Augustinus Wilrijk
Wilrijk
Бразилия (5)
Hospital de Cancer de Barretos
Barretos , São Paulo
Hospital Sao Rafael - HSR
Salvador , Estado de Bahia
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto , São Paulo
Hospital Sírio-Libanês
São Paulo , São Paulo
Hospital Alemao Oswaldo Cruz
São Paulo , São Paulo
Канада (2)
William Osler Health Centre - Brampton Civic Hospital
Brampton , Ontario
Jewish General Hospital
Montreal , Quebec
Дания (3)
Aarhus Universitetshospital
Aarhus N
Herlev Hospital
Herlev
Regionshospitalet Gødstrup
Herning
Финландия (2)
Helsinki University Central Hospital
Helsinki
Kuopio Uni Hospital
Kuopio
Франция (12)
CHRU Brest
Brest
Chu Toulouse
Bron
Hopital Louis Pradel
Bron
CHRU Lille
Lille
Centre Leon Berard
Lyon
CHU Montpellier
Montpellier
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
Nice
Hopital Tenon
Paris
CHU Bordeaux
Pessac
CH de Saint Quentin
Saint-Quentin
Chru de Strasbourg
Strasbourg
Hia Sainte Anne
Toulon
Германия (17)
Evangelische Lungenklinik Berlin
Berlin
Helios Klinikum Emil von Behring GmbH
Berlin
Klinikum Koeln-Merheim
Cologne
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen
Universitätsklinikum Essen
Essen
Klinikum Esslingen
Esslingen am Neckar
Asklepios Fachkliniken GmbH
Gauting
LungenClinic Großhansdorf GmbH
Großhansdorf
Thoraxklinik Heidelberg gGmbH
Heidelberg
Lungenklinik Hemer
Hemer
Universität Des Saarlandes
Homburg
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
Löwenstein
Universitätsklinikum Schleswig-Holstein
Lübeck
Klinikum Bogenhausen
München
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
Münster
Universitätsklinikum Regensburg
Regensburg
Klinikum Würzburg Mitte gGmbH
Würzburg
Гърция (5)
Uoa Sotiria Hospital
Athens
Errikos Dynan Hospital
Athens
University Hospital of Larissa
Larissa
Theageneio Hospital
Thessaloniki
Ag. Loukas Hospital
Thessaloniki
Hong Kong (2)
Tuen Mun Hospital
Hong Kong
Prince of Wales Hosp
Shatin
Италия (8)
Irccs Ist. Tumori Giovanni Paolo Ii
Bari , Apulia
Azienda Ospedaliero-Universitaria Careggi
Florence , Tuscany
Ospedale Policlinico San Martino
Genoa , Liguria
IRCCS Istituto Oncologico Veneto (IOV)
Padova , Veneto
A.O. Universitaria Di Parma
Parma , Emilia-Romagna
Azienda Ospedaliero Universitaria Pisana
Pisa , Tuscany
IRCCS Istituto Regina Elena (IFO)
Rome , Lazio
Ospedale Civile SS Annunziata
Sassari , Sardinia
Япония (6)
Kyushu University Hospital
Fukuoka
Sendai Kousei Hospital
Miyagi
Kindai University Hospital
Osaka
National Cancer Center Hospital
Tokyo
The Cancer Institute Hospital of JFCR
Tokyo
Wakayama Medical University Hospital
Wakayama
Mexico (1)
ARKE Estudios Clínicos S.A. de C.V.
Mexico City
Нидерландия (6)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Ziekenhuis Rijnstate
Arnhem
Amphia Ziekenhuis
Breda
Ziekenhuis St. Jansdal
Harderwijk
Medisch Centrum Haaglanden, locatie Antoniushove
Leidschendam
Isala
Zwolle
Полша (3)
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk
Instytut Gruzlicy I Chorob Pluc
Warsaw
Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii
Wroc?aw
Португалия (5)
Hospital de Braga
Braga
CHUC - Unidade de Pneumologia Oncológica
Coimbra
Centro Clinico Champalimaud
Lisbon
Centro Hospitalar do Porto ? Hospital de Santo António
Porto
IPO do Porto
Porto
Сингапур (1)
National Cancer Centre
Singapore
Южна Корея (6)
St. Vincent's Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Chonnam National University Hwasun Hospital
Jeollanam-do
Seoul National University Bundang Hospital
Seongnam-si
Seoul National University Hospital
Seoul
Samsung Medical Center
Seoul
Испания (8)
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Vall Hebron
Barcelona
Institut Catala d Oncologia Hospitalet
L'Hospitalet de Llobregat , Barcelona
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Regional Universitario de Malaga
Málaga
Hospital Nuestra Senora de Valme
Seville , Sevilla
Hospital Universitario la Fe
Valencia
Hospital Universitario Miguel Servet
Zaragoza
Швеция (1)
Gävle Sjukhus
Gävle
Taiwan (3)
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation - Linkou
Taoyuan District
Тайланд (3)
Vajira Hospital
Bangkok
Siriraj Hospital - Chulabhorn Bone Marrow Transplant Centre
Bangkok
Songklanagarind Hospital
Songkhla
Великобритания (9)
Addenbrooke's Hospital
Cambridge
Castle Hill Hospital
Cottingham
Beatson West of Scotland Cancer Centre
Glasgow
St James University Hospital
Leeds
Guy's Hospital - Cancer Centre
London
Royal Marsden Hospital - London
London
Nottingham City Hospital
Nottingham
Royal Marsden Hospital (Sutton)
Sutton
Torbay Hospital
Torquay
САЩ (25)
University of Michigan
Ann Arbor , Michigan
Dana Farber Cancer Institute
Boston , Massachusetts
Tennessee Oncology, PLLC - Chattanooga
Chattanooga , Tennessee
University of Chicago Medical Center
Chicago , Illinois
Minnesota Oncology Edina
Edina , Minnesota
Oncology Associates of Oregon, P.C
Eugene , Oregon
JPS Health Network
Fort Worth , Texas
Banner Health MD Anderson AZ
Gilbert , Arizona
Cancer and Hematology Centers of Western Michigan
Grand Rapids , Michigan
MD Anderson Cancer Center
Houston , Texas
Texas Oncology - Northeast Texas
Longview , Texas
Los Angeles Cancer Network
Los Angeles , California
UCLA Hematology / Oncology Clinic
Los Angeles , California
Taylor Cancer Research Center
Maumee , Ohio
Baptist Clinical Research Institute
Memphis , Tennessee
University of Miami
Miami , Florida
Tennessee Oncology
Nashville , Tennessee
Yale Cancer Center
New Haven , Connecticut
Columbia University Medical Center
New York , New York
Fox Chase Cancer Center
Philadelphia , Pennsylvania
Allegheny Cancer Center
Pittsburgh , Pennsylvania
Oregon Health & Science University
Portland , Oregon
University of California, San Francisco
San Francisco , California
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
St. Petersburg , Florida
New England Cancer Specialists
Westbrook , Maine
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.09.2024
Крайна дата
30.11.2029
Регистрационен номер
NCT06497556
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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