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RocheA 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 (Krascendo 1) Fase III 338
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06497556 (Krascendo 1) está diseñado para estudiar el tratamiento de Cáncer de pulmón de células no pequeñas, KRAS G12C Lung Cancer. Es un estudio intervencionista de Fase III. Su estado actual es: activo, no reclutando. El estudio se inició el 23 de septiembre de 2024, con el objetivo de reclutar a 338 participantes. Dirigido por Roche, se espera que finalice el 30 de noviembre de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 20 de enero de 2026.
Resumen
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).
Título oficial
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
Condiciones médicas
Cáncer de pulmón de células no pequeñasKRAS G12C Lung CancerOtros ID del estudio
- Krascendo 1
- BO45217
- 2024-510908-37-00 (Otro identificador) (EU CT Number)
Número del NCT
Inicio del estudio (real)
2024-09-23
Última actualización
2026-01-20
Fecha de finalización (estimada)
2029-11-30
Inscripción (prevista)
338
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Activo, no reclutando
Palabras clave
Advanced Non-Small Cell Lung Cancer
KRAS G12 Lung Cancer
Advanced Lung Cancer
Metastatic lung cancer
Divarasib
KRAS G12C Inhibitor
KRAS G12C Positive
KRAS Mutation
KRAS G12C Mutation
Lung Cancer Mutation
KRAS G12 Lung Cancer
Advanced Lung Cancer
Metastatic lung cancer
Divarasib
KRAS G12C Inhibitor
KRAS G12C Positive
KRAS Mutation
KRAS G12C Mutation
Lung Cancer Mutation
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalDivarasib Participants will receive divarasib orally, once daily (QD). | Divarasib Divarasib will be administered orally QD |
Comparador activoKRAS G12C inhibitor Participants will receive sotorasib orally QD or adagrasib orally twice a day (BID) | Sotorasib Sotorasib will be administered orally QD Adagrasib Adagrasib will be administred orally BID |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first) | Up to approximately 4 years |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Overall Survival (OS) | OS is defined as the time from randomization to death from any cause | Up to approximately 4 years |
Confirmed Objective Response | Confirmed objective response is defined as complete response (CR) or partial response (PR) on two occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1 | Up to approximately 4 years |
Time to Confirmed Deterioration (TTCD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Dyspnea Item and Physical Functioning Scale | Baseline up to approximately 4 years | |
TTCD on the EORTC Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (QLQ-LC13) Cough Scale | Baseline up to approximately 4 years | |
Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a documented confirmed objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first) | Up to approximately 4 years |
Percentage of Participants with Adverse Events (AEs) | Up to approximately 4 years | |
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to approximately 4 years | |
Change from Baseline in Diarrhea, Nausea, Vomiting, Anorexia, Alopecia, Dyspnea, Cough, Constipation, Myalgia, Headache, and Rash/Acne as Assessed Through use of the NCI PRO-CTCAE | Baseline up to approximately 4 years | |
Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46) | Up to approximately 4 years | |
Change from Baseline in Cough, Chest Pain, Dyspnea, Physical and Role Functioning, and Global Health Status score/Quality of Life Score (GHS/QoL) at Each Timepoint as Assessed Through use of the EORTC QLQ-LC13 and QLQ-C30 | Baseline up to approximately 4 years | |
TTCD on the EORTC QLQ-C30 Role Functioning and GHS/QoL scales | Up to approximately 4 years | |
TTCD on the Chest Pain Scale of the QLQ-LC13 Scales | Up to approximately 4 years |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- 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
- 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
Chugai PharmaceuticalNo hay datos de contacto.
151 Centros del estudio en 26 países
Barcelona
Institut Catala d Oncologia Hospitalet, L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Sevilla
Hospital Nuestra Senora de Valme, Seville, Sevilla, 41014, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, 08025, Spain
Hospital Vall Hebron, Barcelona, Spain
Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
Hospital Universitario la Fe, Valencia, 46026, Spain
Hospital Universitario Miguel Servet, Zaragoza, 50009, Spain
ARKE Estudios Clínicos S.A. de C.V., Mexico City, 06700, Mexico
Hospital Britanico, Buenos Aires, C1280AEB, Argentina
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires, C1426AGE, Argentina
Arizona
Banner Health MD Anderson AZ, Gilbert, Arizona, 85234, United States
California
Los Angeles Cancer Network, Los Angeles, California, 90017-4803, United States
UCLA Hematology / Oncology Clinic, Los Angeles, California, 90095, United States
University of California, San Francisco, San Francisco, California, 94158, United States
Connecticut
Yale Cancer Center, New Haven, Connecticut, 06519, United States
Florida
University of Miami, Miami, Florida, 33136, United States
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg), St. Petersburg, Florida, 33701-4553, United States
Illinois
University of Chicago Medical Center, Chicago, Illinois, 60637, United States
Maine
New England Cancer Specialists, Westbrook, Maine, 04092, United States
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Michigan
University of Michigan, Ann Arbor, Michigan, 48109-0934, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, 49503, United States
Minnesota
Minnesota Oncology Edina, Edina, Minnesota, 55435, United States
New York
Columbia University Medical Center, New York, New York, 10032, United States
Ohio
Taylor Cancer Research Center, Maumee, Ohio, 43537, United States
Oregon
Oncology Associates of Oregon, P.C, Eugene, Oregon, 97401, United States
Oregon Health & Science University, Portland, Oregon, 97239, United States
Pennsylvania
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States
Allegheny Cancer Center, Pittsburgh, Pennsylvania, 15212, United States
Tennessee
Tennessee Oncology, PLLC - Chattanooga, Chattanooga, Tennessee, 37404, United States
Baptist Clinical Research Institute, Memphis, Tennessee, 38120, United States
Tennessee Oncology, Nashville, Tennessee, 37203, United States
Texas
JPS Health Network, Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Texas Oncology - Northeast Texas, Longview, Texas, 75601, United States
New South Wales
Liverpool Hospital, Liverpool, New South Wales, 2170, Australia
GenesisCare North Shore, St Leonards, New South Wales, 2065, Australia
Queensland
Sunshine Coast University Hospital, Birtinya, Queensland, 4575, Australia
South Australia
Lyell McEwin Hospital, Elizabeth Vale, South Australia, 5112, Australia
Victoria
Peter Maccallum Cancer Centre, Melbourne, Victoria, 3000, Australia
Krankenhaus Nord - Klinik Floridsdorf, Vienna, 1210, Austria
AZORG Campus Aalst-Moorselbaan, Aalst, 9300, Belgium
UZ Brussel, Brussels, 1090, Belgium
Cliniques Universitaires St-Luc, Brussels, 1200, Belgium
UZ Antwerpen, Edegem, 2650, Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, 3500, Belgium
CHU de Liège (Sart Tilman), Liège, 4000, Belgium
CHU UCL Mont-Godinne, Mont-godinne, 5530, Belgium
AZ Delta (Campus Rumbeke), Roeselare, 8800, Belgium
Vitaz, Sint-Niklaas, 9100, Belgium
ZAS Sint Augustinus Wilrijk, Wilrijk, 2610, Belgium
Estado de Bahia
Hospital Sao Rafael - HSR, Salvador, Estado de Bahia, 41253-190, Brazil
São Paulo
Hospital de Cancer de Barretos, Barretos, São Paulo, 14784-400, Brazil
Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Sírio-Libanês, São Paulo, São Paulo, 01308-050, Brazil
Hospital Alemao Oswaldo Cruz, São Paulo, São Paulo, 01323-903, Brazil
Ontario
William Osler Health Centre - Brampton Civic Hospital, Brampton, Ontario, L6R 3J7, Canada
Quebec
Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada
Aarhus Universitetshospital, Aarhus N, 8200, Denmark
Herlev Hospital, Herlev, 2730, Denmark
Regionshospitalet Gødstrup, Herning, 7400, Denmark
Helsinki University Central Hospital, Helsinki, 00029, Finland
Kuopio Uni Hospital, Kuopio, 70211, Finland
CHRU Brest, Brest, 29200, France
Chu Toulouse, Bron, 69500, France
Hopital Louis Pradel, Bron, 69677, France
CHRU Lille, Lille, 59037, France
Centre Leon Berard, Lyon, 69373, France
CHU Montpellier, Montpellier, 34295, France
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer, Nice, 06100, France
Hopital Tenon, Paris, 75970, France
CHU Bordeaux, Pessac, 33604, France
CH de Saint Quentin, Saint-Quentin, 2100, France
Chru de Strasbourg, Strasbourg, 67091, France
Hia Sainte Anne, Toulon, 83041, France
Evangelische Lungenklinik Berlin, Berlin, 13125, Germany
Helios Klinikum Emil von Behring GmbH, Berlin, 14165, Germany
Klinikum Koeln-Merheim, Cologne, 51109, Germany
KEM/Evang. Kliniken Essen Mitte gGmbH, Essen, 45136, Germany
Universitätsklinikum Essen, Essen, 45147, Germany
Klinikum Esslingen, Esslingen am Neckar, 73730, Germany
Asklepios Fachkliniken GmbH, Gauting, 82131, Germany
LungenClinic Großhansdorf GmbH, Großhansdorf, 22927, Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, 69126, Germany
Lungenklinik Hemer, Hemer, 58675, Germany
Universität Des Saarlandes, Homburg, 66421, Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein, Löwenstein, 74245, Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, 23538, Germany
Klinikum Bogenhausen, München, 81925, Germany
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie, Münster, 48149, Germany
Universitätsklinikum Regensburg, Regensburg, 93053, Germany
Klinikum Würzburg Mitte gGmbH, Würzburg, 97074, Germany
Uoa Sotiria Hospital, Athens, 115 27, Greece
Errikos Dynan Hospital, Athens, 11526, Greece
University Hospital of Larissa, Larissa, 411 10, Greece
Theageneio Hospital, Thessaloniki, 546 39, Greece
Ag. Loukas Hospital, Thessaloniki, 55236, Greece
Tuen Mun Hospital, Hong Kong, Hong Kong
Prince of Wales Hosp, Shatin, Hong Kong
Apulia
Irccs Ist. Tumori Giovanni Paolo Ii, Bari, Apulia, 70124, Italy
Emilia-Romagna
A.O. Universitaria Di Parma, Parma, Emilia-Romagna, 43100, Italy
Lazio
IRCCS Istituto Regina Elena (IFO), Rome, Lazio, 00144, Italy
Liguria
Ospedale Policlinico San Martino, Genoa, Liguria, 16132, Italy
Sardinia
Ospedale Civile SS Annunziata, Sassari, Sardinia, 07100, Italy
Tuscany
Azienda Ospedaliero-Universitaria Careggi, Florence, Tuscany, 50139, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, Tuscany, 56126, Italy
Veneto
IRCCS Istituto Oncologico Veneto (IOV), Padua, Veneto, 35128, Italy
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Sendai Kousei Hospital, Miyagi, 981-0914, Japan
Kindai University Hospital, Osaka, 589-8511, Japan
National Cancer Center Hospital, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
Wakayama Medical University Hospital, Wakayama, 641-8510, Japan
Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, 5223 GZ, Netherlands
Ziekenhuis Rijnstate, Arnhem, 6815 AD, Netherlands
Amphia Ziekenhuis, Breda, 4818CK, Netherlands
Ziekenhuis St. Jansdal, Harderwijk, 3844 DG, Netherlands
Medisch Centrum Haaglanden, locatie Antoniushove, Leidschendam, 2262 BA, Netherlands
Isala, Zwolle, 8025 AB, Netherlands
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk, 80-214, Poland
Instytut Gruzlicy I Chorob Pluc, Warsaw, 01-138, Poland
Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii, Wroc?aw, 53-439, Poland
Hospital de Braga, Braga, 4710-243, Portugal
CHUC - Unidade de Pneumologia Oncológica, Coimbra, 3000-075, Portugal
Centro Clinico Champalimaud, Lisbon, 1400-038, Portugal
Centro Hospitalar do Porto ? Hospital de Santo António, Porto, 4099-001, Portugal
IPO do Porto, Porto, 4200-072, Portugal
National Cancer Centre, Singapore, 168583, Singapore
St. Vincent's Hospital, Gyeonggi-do, 16247, South Korea
Gachon University Gil Medical Center, Incheon, 21565, South Korea
Chonnam National University Hwasun Hospital, Jeollanam-do, 58128, South Korea
Seoul National University Bundang Hospital, Seongnam-si, 463-707, South Korea
Seoul National University Hospital, Seoul, 03080, South Korea
Samsung Medical Center, Seoul, 06351, South Korea
Gävle Sjukhus, Gävle, 80187, Sweden
National Taiwan University Hospital, Taipei, 00100, Taiwan
Taipei Veterans General Hospital, Taipei, 112, Taiwan
Chang Gung Medical Foundation - Linkou, Taoyuan District, 333, Taiwan
Vajira Hospital, Bangkok, 10300, Thailand
Siriraj Hospital - Chulabhorn Bone Marrow Transplant Centre, Bangkok, 10700, Thailand
Songklanagarind Hospital, Songkhla, 90110, Thailand
Addenbrooke's Hospital, Cambridge, CB2 0QQ, United Kingdom
Castle Hill Hospital, Cottingham, HU16 5JQ, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, G12 0YN, United Kingdom
St James University Hospital, Leeds, LS9 7TF, United Kingdom
Guy's Hospital - Cancer Centre, London, SE1 9RT, United Kingdom
Royal Marsden Hospital - London, London, SW3 6JJ, United Kingdom
Nottingham City Hospital, Nottingham, NG5 1PB, United Kingdom
Royal Marsden Hospital (Sutton), Sutton, SM2 5PT, United Kingdom
Torbay Hospital, Torquay, TQ27AA, United Kingdom