A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Non-small Cell Lung Cancer
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 675 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.
The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
- If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has a gastrointestinal disorder affecting absorption
- Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy except those specified by protocol
- Has history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Calderasib + Pembrolizumab (+) Berahyaluronidase alfa
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus calderasib until discontinuation criterion is met.
Drug: Calderasib · Biological: Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).
Biological: Pembrolizumab (+) Berahyaluronidase alfa · Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin
Calderasib DRUG
Administered as an oral tablet
Pembrolizumab (+) Berahyaluronidase alfa BIOLOGICAL
Administered as a SC injection
Pemetrexed DRUG
Administered as an IV Infusion
Cisplatin DRUG
Administered as an IV Infusion
Carboplatin DRUG
Administered as an IV Infusion
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Plazo: Up to approximately 48 months
PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
Medidas secundarias
PFS in All Participants
Plazo: Up to approximately 48 months
PFS is defined as the time from randomization until either documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS as determined by BICR will be presented.
Overall Survival (OS) in Participants with PD-L1 TPS ≥1%
Plazo: Up to approximately 62 months
OS is defined as the time from randomization to death due to any cause.
OS in Participants in All Participants
Plazo: Up to approximately 62 months
OS is defined as the time from randomization to death due to any cause.
Overall Response Rate (ORR) in All Participants
Plazo: Up to approximately 48 months
ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
ORR in Participants with PD-L1 TPS ≥1%
Plazo: Up to approximately 48 months
ORR is defined as the percentage of participants with CR or PR per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Duration of Response (DOR)
Plazo: Up to approximately 48 months
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experienced One or More Adverse Events (AEs)
Plazo: Up to approximately 81 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinued Study Treatment Due to an AE
Plazo: Up to approximately 81 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.
Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
Plazo: Baseline and up to approximately 81 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. Higher scores indicate a better overall health status.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Plazo: Baseline and up to approximately 81 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. A higher score indicates a worse level of dyspnea.
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13)
Plazo: Baseline and up to approximately 81 months
The EORTC QLQ-C13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. A higher score indicates more frequent coughing.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Plazo: Baseline and up to approximately 81 months
The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. A higher score indicates a worse level of chest pain.
Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30
Plazo: Baseline and up to approximately 81 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in global health status (GHS) and quality of life (QoL) (EORTC QLQ-C30 Items 29 and 30) score. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in GHS and QoL, will be presented. A longer TTD indicates a better outcome.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Plazo: Baseline and up to approximately 81 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in dyspnea (EORTC QLQ-C30 Item 8) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
Plazo: Baseline and up to approximately 81 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in cough (EORTC QLQ-C13 Item 31) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in cough score, will be presented. A longer TTD indicates a better outcome.
TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Plazo: Baseline and up to approximately 81 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in chest pain (EORTC QLQ-C13 Item 40) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline chest pain score, will be presented. A longer TTD indicates a better outcome.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (225)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
225 centros
Central Alabama Research ( Site 0108)Birmingham, Alabama, United StatesReclutando
Beverly Hills Cancer Center ( Site 0142)Beverly Hills, California, United StatesReclutando
University of Connecticut Health Center ( Site 0130)Farmington, Connecticut, United StatesReclutando
Stamford Hospital ( Site 0126)Stamford, Connecticut, United StatesReclutando
The Oncology Institute of Hope and Innovation ( Site 0161)Fort Lauderdale, Florida, United StatesReclutando
Mount Sinai Cancer Center ( Site 0137)Miami Beach, Florida, United StatesCompletado
Low Country Cancer Care ( Site 0156)Savannah, Georgia, United StatesReclutando
Indiana University Health Arnett Cancer Center ( Site 0116)Lafayette, Indiana, United StatesReclutando
New England Cancer Specialists ( Site 0139)Westbrook, Maine, United StatesReclutando
Minneapolis VA Medical Center ( Site 0145)Minneapolis, Minnesota, United StatesReclutando
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)Hackensack, New Jersey, United StatesReclutando
New York Oncology Hematology, P.C. ( Site 0119)Albany, New York, United StatesReclutando
Wilmot Cancer Institute ( Site 0141)Rochester, New York, United StatesReclutando
St. Charles Health System, Inc ( Site 0146)Bend, Oregon, United StatesReclutando
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)Lancaster, Pennsylvania, United StatesReclutando
Hematology Oncology Associates of Fredericksburg ( Site 9550)Fredericksburg, Virginia, United StatesReclutando
Bon Secours Cancer Institute at St. Francis ( Site 0148)Midlothian, Virginia, United StatesReclutando
Blue Ridge Cancer Care ( Site 0144)Roanoke, Virginia, United StatesReclutando
WVU Cancer Institute ( Site 0153)Morgantown, West Virginia, United StatesReclutando
Instituto Alexander Fleming ( Site 0311)Ciudad Autónoma de Buenos Aires, Buenos Aires, ArgentinaReclutando
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)Mar del Plata, Buenos Aires, ArgentinaReclutando
Hospital Italiano de Cordoba ( Site 0308)Córdoba, ArgentinaReclutando
CEMAIC ( Site 0309)Córdoba, ArgentinaReclutando
Genesis Care- Campbelltown ( Site 2907)Campbelltown, New South Wales, AustraliaReclutando
Northern Beaches Hospital ( Site 2905)Frenchs Forest, New South Wales, AustraliaReclutando
The Prince Charles Hospital ( Site 2903)Brisbane, Queensland, AustraliaReclutando
Mater Hospital Brisbane ( Site 2906)South Brisbane, Queensland, AustraliaReclutando
Peninsula & South Eastern Haematology and Oncology Group ( Site 2908)Frankston, Victoria, AustraliaReclutando
Klinikum Klagenfurt am Wörthersee ( Site 1002)Klagenfurt, Carinthia, AustriaReclutando
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)Graz, Styria, AustriaReclutando
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)Vienna, AustriaReclutando
Algemeen Ziekenhuis Klina ( Site 3904)Brasschaat, Antwerpen, BelgiumReclutando
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)Genk, Limburg, BelgiumReclutando
VITAZ ( Site 3902)Sint-Niklaas, Oost-Vlaanderen, BelgiumReclutando
Clinical Chc Montlégia ( Site 3901)Liège, BelgiumReclutando
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)Fortaleza, Ceará, BrazilReclutando
Hospital Santa Rita de Cassia ( Site 0403)Vitória, Espírito Santo, BrazilReclutando
Real Hospital Portugues ( Site 0418)Recife, Pernambuco, BrazilReclutando
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)Porto Alegre, Rio Grande do Sul, BrazilReclutando
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)Florianópolis, Santa Catarina, BrazilReclutando
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)Ribeirão Preto, São Paulo, BrazilReclutando
Faculdade de Medicina do ABC ( Site 0411)Santo André, São Paulo, BrazilReclutando
Hospital Alemao Oswaldo Cruz ( Site 0413)São Paulo, São Paulo, BrazilReclutando
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)São Paulo, BrazilReclutando
Cross Cancer Institute ( Site 0203)Edmonton, Alberta, CanadaReclutando
Sunnybrook Research Institute ( Site 0209)Toronto, Ontario, CanadaReclutando
Centro de Estudios Clínicos SAGA ( Site 0503)Santiago, Region M. de Santiago, ChileReclutando
Fundación Arturo López Pérez ( Site 0500)Santiago, Region M. de Santiago, ChileReclutando
Bradfordhill ( Site 0501)Santiago, Region M. de Santiago, ChileReclutando
Anhui Provincial Cancer Hospital ( Site 2708)Hefei, Anhui, ChinaReclutando
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)Beijing, Beijing Municipality, ChinaReclutando
Beijing Peking Union Medical College Hospital ( Site 2702)Beijing, Beijing Municipality, ChinaReclutando
The First Affiliated Hospital of Fujian Medical University ( Site 2701)Fujian, Fujian, ChinaReclutando
Fujian Provincial Cancer Hospital ( Site 2706)Fuzhou, Fujian, ChinaReclutando
The First Affiliated Hospital of Xiamen University ( Site 2717)Fuzhou, Fujian, ChinaReclutando
The First Affiliated Hospital.Sun Yat-sen University ( Site 2714)Guangzhou, Guangdong, ChinaReclutando
AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)Guangzhou, Guangdong, ChinaReclutando
Zhujiang Hospital of Southern Medical University ( Site 2744)Guangzhou, Guangdong, ChinaReclutando
Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)Nanning, Guangxi, ChinaReclutando
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)Jiamusi, Heilongjiang, ChinaReclutando
Henan Cancer Hospital ( Site 2746)Zhengzhou, Henan, ChinaReclutando
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)Wuhan, Hubei, ChinaReclutando
Hubei Cancer Hospital ( Site 2721)Wuhan, Hubei, ChinaReclutando
Xiangya Hospital Central South University ( Site 2741)Changsha, Hunan, ChinaReclutando
Hunan Cancer Hospital ( Site 2710)Changsha, Hunan, ChinaReclutando
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)Nanjing, Jiangsu, ChinaActivo, sin reclutamiento
Jiangxi Cancer Hospital ( Site 2725)Nanchang, Jiangxi, ChinaReclutando
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2729)Xi'an, Shaanxi, ChinaReclutando
LinYi Cancer Hospital ( Site 2737)Linyi, Shandong, ChinaReclutando
Shanghai Chest Hospital ( Site 2747)Shanghai, Shanghai Municipality, ChinaReclutando
Shanghai Pulmonary Hospital-Oncology Department ( Site 2723)Shanghai, Shanghai Municipality, ChinaReclutando
Shanxi Cancer Hospital ( Site 2728)Taiyuan, Shanxi, ChinaReclutando
Sichuan Cancer Hospital. ( Site 2739)Chengdu, Sichuan, ChinaReclutando
West China Hospital Sichuan University ( Site 2735)Chengdu, Sichuan, ChinaReclutando
Chongqing University Cancer Hospital ( Site 2736)Chongqing, Sichuan, ChinaReclutando
Yunnan Province Cancer Hospital ( Site 2734)Kunming, Yunnan, ChinaReclutando
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2716)Hangzhou, Zhejiang, ChinaReclutando
Sir Run Run Shaw Hospital ( Site 2731)Hangzhou, Zhejiang, ChinaReclutando
Zhejiang Cancer Hospital ( Site 2727)Hangzhou, Zhejiang, ChinaReclutando
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)Taizhou, Zhejiang, ChinaReclutando
Promotora Médica Las Américas S.A. ( Site 0608)Medellín, Antioquia, ColombiaReclutando
Hospital Universitario San Ignacio ( Site 0604)Bogotá, Bogota D.C., ColombiaReclutando
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)Bogotá, Bogota D.C., ColombiaReclutando
Hopital Europeen Marseille ( Site 1207)Marseille, Bouches-du-Rhone, FranceReclutando
CHU Caen ( Site 1212)Caen, Calvados, FranceReclutando
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)Vandœuvre-lès-Nancy, Meurthe-et-Moselle, FranceReclutando
Centre Hospitalier de Pau ( Site 1217)Pau, Pyrenees-Atlantiques, FranceReclutando
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)Chambéry, Savoie, FranceReclutando
Clinique de l'Europe ( Site 1213)Amiens, Somme, FranceReclutando
Groupe Hospitalier Paris Saint Joseph ( Site 1215)Paris, FranceReclutando
Hôpital Européen Georges Pompidou ( Site 1214)Paris, FranceReclutando
Agios Andreas Hospital Patras ( Site 1407)Pátrai, Achaia, GreeceReclutando
Errikos Dunant Hospital Center ( Site 1408)Athens, Attica, GreeceReclutando
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1409)Athens, Attica, GreeceReclutando
General Hospital of Athens "Laiko" ( Site 1402)Athens, Attica, GreeceReclutando
Metropolitan General Hospital ( Site 1400)Athens, Attica, GreeceReclutando
Papageorgiou General Hospital of Thessaloniki ( Site 1403)Thessaloniki, GreeceReclutando
MEDI-K ( Site 3803)Guatemala City, GuatemalaActivo, sin reclutamiento
Centro Integral De Oncologia Gastrointestinal Y Hemato-Oncologia De Guatemala, S. A ( Site 3802)Guatemala City, GuatemalaReclutando
Servicios Médicos Oncológicos ( Site 3804)Guatemala City, GuatemalaReclutando
Nograd Varmegyei Szent Lazar Korhaz ( Site 1509)Salgótarján, Nógrád megye, HungaryReclutando
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)Budapest, Pest County, HungaryReclutando
Reformatus Pulmonologiai Centrum ( Site 1503)Törökbálint, Pest County, HungaryReclutando
Yitzhak Shamir Medical Center. ( Site 1709)Beer Ya Akov, IsraelReclutando
Shaare Zedek Medical Center ( Site 1706)Jerusalem, IsraelReclutando
Meir Medical Center. ( Site 1702)Kfar Saba, IsraelReclutando
Sheba Medical Center ( Site 1700)Ramat Gan, IsraelReclutando
Sourasky Medical Center ( Site 1705)Tel Aviv, IsraelReclutando
Azienda Santiaria dell'Alto Adige, comprensorio di Bolzano ( Site 1818)Bolzano, Bozen, ItalyReclutando
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 1815)Modena, Emilia-Romagna, ItalyReclutando
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)Meldola, Forli-Cesena, ItalyReclutando
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale ( Site 1813)Udine, Friuli Venezia Giulia, ItalyReclutando
Azienda Ospedaliera S. Giovanni Addolorata ( Site 1805)Rome, Lazio, ItalyReclutando
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)Bergamo, Lombardy, ItalyReclutando
Istituto Clinico Humanitas ( Site 1812)Rozzano, Milano, ItalyReclutando
Ospedale San Giuseppe Moscati ( Site 1816)Statte, Taranto, ItalyReclutando
AOU Careggi ( Site 1801)Florence, Tuscany, ItalyReclutando
AOU Renato Dulbecco ( Site 1804)Catanzaro, ItalyReclutando
Ospedale San Raffaele. ( Site 1806)Milan, ItalyReclutando
ASST Grande Ospedale Metropolitano Niguarda ( Site 1817)Milan, ItalyReclutando
A.O.R.N. Antonio Cardarelli ( Site 1810)Naples, ItalyReclutando
Policlinico San Matteo ( Site 1802)Pavia, ItalyReclutando
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)Verona, ItalyReclutando
Aichi Cancer Center ( Site 2813)Nagoya, Aichi-ken, JapanReclutando
Fujita Health University Hospital ( Site 2807)Toyoake, Aichi-ken, JapanReclutando
Hirosaki University Hospital ( Site 2818)Hirosaki, Aomori, JapanReclutando
Ehime University Hospital ( Site 2800)Tōon, Ehime, JapanReclutando
Kurume University Hospital ( Site 2815)Kurume, Fukuoka, JapanReclutando
Gunma Prefectural Cancer Center ( Site 2802)Ōta, Gunma, JapanActivo, sin reclutamiento
National Hospital Organization Himeji Medical Center ( Site 2827)Himeji, Hyōgo, JapanReclutando
Kobe City Medical Center General Hospital ( Site 2811)Kobe, Hyōgo, JapanReclutando
Takarazuka City Hospital ( Site 2828)Takarazuka, Hyōgo, JapanReclutando
Kanazawa University Hospital ( Site 2805)Kanazawa, Ishikawa-ken, JapanReclutando
St. Marianna University Hospital ( Site 2814)Kawasaki, Kanagawa, JapanReclutando
Yokohama Municipal Citizen's Hospital ( Site 2824)Yokohama, Kanagawa, JapanReclutando
Kanagawa Cancer Center ( Site 2820)Yokohama, Kanagawa, JapanReclutando
Saiseikai Matsusaka Municipal Hospital ( Site 2808)Matsusaka, Mie-ken, JapanReclutando
Tohoku University Hospital ( Site 2804)Sendai, Miyagi, JapanReclutando
Kansai Medical University Hospital ( Site 2809)Hirakata, Osaka, JapanReclutando
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)Sakai, Osaka, JapanReclutando
Osaka Medical and Pharmaceutical University Hospital ( Site 2810)Takatsuki, Osaka, JapanReclutando
National Hospital Organization Ureshino Medical Center ( Site 2817)Ureshino, Saga-ken, JapanReclutando
Nippon Medical School Hospital ( Site 2819)Bunkyo, Tokyo, JapanReclutando
Tokyo Metropolitan Komagome Hospital ( Site 2823)Bunkyo, Tokyo, JapanReclutando
Toho University Omori Medical Center ( Site 2825)Ōta-ku, Tokyo, JapanReclutando
Tokyo Medical University Hospital ( Site 2829)Shinjuku, Tokyo, JapanReclutando
National Center for Global Health and Medicine ( Site 2806)Shinjuku, Tokyo, JapanReclutando
Chiba University Hospital ( Site 2812)Chiba, JapanReclutando
National Hospital Organization Kyushu Medical Center ( Site 2801)Fukuoka, JapanReclutando
Hiroshima City Hiroshima Citizens Hospital ( Site 2821)Hiroshima, JapanReclutando
Saiseikai Kumamoto Hospital ( Site 2816)Kumamoto, JapanReclutando
Osaka Metropolitan University Hospital ( Site 2826)Osaka, JapanReclutando
Sultan Ismail Hospital ( Site 3103)Johor Bahru, Johor, MalaysiaReclutando
University Malaya Medical Centre ( Site 3107)Wilayah Persekutuan, Kuala Lumpur, MalaysiaReclutando
Hospital Tengku Ampuan Afzan ( Site 3109)Kuantan, Pahang, MalaysiaReclutando
Hospital Pulau Pinang ( Site 3108)George Town, Pulau Pinang, MalaysiaReclutando
Hospital Wanita and Kanak Kanak Sabah ( Site 3110)Kota Kinabalu, Sabah, MalaysiaReclutando
Sarawak General Hospital ( Site 3101)Kuching, Sarawak, MalaysiaReclutando
Sunway Medical Centre ( Site 3106)Petaling Jaya, Selangor, MalaysiaReclutando
Cengild G.I. Medical Centre ( Site 3112)Kuala Lumpur, MalaysiaReclutando
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0801)Guadalajara, Jalisco, MexicoReclutando
Grupo Médico ASSET SC ( Site 0811)Benito Juárez, Mexico City, MexicoReclutando
Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0800)Monterrey, Nuevo León, MexicoReclutando
Centro de Investigacion Clinica de Oaxaca ( Site 0813)Oaxaca City, Oaxaca, MexicoReclutando
Scientia Investigacion Clinica S.C. ( Site 0804)Chihuahua City, MexicoReclutando
Instituto Nacional de Cancerologia. ( Site 0808)Mexico City, MexicoReclutando
Clinica Integral Internacional de Oncología ( Site 0812)Puebla City, MexicoReclutando
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)Breda, North Brabant, NetherlandsReclutando
Elisabeth-TweeSteden Ziekenhuis ( Site 1906)Tilburg, North Holland, NetherlandsReclutando
University Medical Center Groningen ( Site 1908)Groningen, NetherlandsReclutando
Universitair Medisch Centrum Utrecht ( Site 1901)Utrecht, NetherlandsReclutando
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0902)Lima, PeruReclutando
Oncosalud ( Site 0901)Lima, PeruReclutando
Hospital Nacional Edgardo Rebagliati Martins ( Site 0903)Lima, PeruReclutando
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)Przemyśl, Podkarpackie Voivodeship, PolandReclutando
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)Gliwice, Silesian Voivodeship, PolandReclutando
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)Olsztyn, Warmian-Masurian Voivodeship, PolandReclutando
Spitalul Clinic Colțea ( Site 2102)Bucharest, Bucharest, RomaniaReclutando
Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)Cluj-Napoca, Cluj, RomaniaReclutando
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)Florești, Cluj, RomaniaReclutando
Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)Craiova, Dolj, RomaniaReclutando
Spitalul Municipal Schuller Ploiești ( Site 2106)Ploieşti, Prahova, RomaniaReclutando
SC ONCO CARD SRL ( Site 2109)Brasov, RomaniaReclutando
SC MNT Healthcare Europe SRL ( Site 2105)Bucharest, RomaniaReclutando
Delta Health Care SRL ( Site 2108)Bucharest, RomaniaReclutando
Chonnam National University Hwasun Hospital ( Site 3502)Jeollanam-do, Jeonranamdo, South KoreaReclutando
Pusan National University Yangsan Hospital ( Site 3504)Yangsan, Kyongsangnam-do, South KoreaReclutando
Pusan National University Hospital ( Site 3501)Busan, Pusan-Kwangyokshi, South KoreaReclutando
Chungnam National University Hospital ( Site 3503)Daejeon, Taejon-Kwangyokshi, South KoreaReclutando
Kyung Hee University Medical Center ( Site 3500)Seoul, South KoreaReclutando
Korea University Guro Hospital ( Site 3505)Seoul, South KoreaReclutando
Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)Badalona, Catalonia, SpainReclutando
HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)Barcelona, Catalonia, SpainReclutando
Complejo Hospitalario Universitario A Coruna ( Site 2207)A Coruña, La Coruna, SpainReclutando
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)Majadahonda, Madrid, Comunidad de, SpainReclutando
Hospital General Universitario de Valencia ( Site 2204)Valencia, Valenciana, Comunitat, SpainReclutando
Hospital Universitario Ramon y Cajal ( Site 2203)Madrid, SpainReclutando
Hospital Universitario Virgen de Valme ( Site 2205)Seville, SpainReclutando
Klinik fur Hamatologie und Onkologie Hirslanden Zurich ( Site 4001)Zurich, SwitzerlandReclutando
Stadtspital Zürich Triemli - Klinik für Medizinische Onkologie und Hämatologie ( Site 4000)Zurich, SwitzerlandReclutando
Chang Gung Memorial Hospital- Chiayi ( Site 3611)Chiayi City, Chiayi, TaiwanReclutando
Taipei Medical University Shuang Ho Hospital ( Site 3602)New Taipei City, TaiwanReclutando
National Cheng Kung University Hospital ( Site 3604)Tainan, TaiwanReclutando
MacKay Memorial Hospital ( Site 3609)Taipei, TaiwanReclutando
National Taiwan University Cancer Center (NTUCC) ( Site 3601)Taipei, TaiwanReclutando
Tri-Service General Hospital ( Site 3603)Taipei, TaiwanReclutando
Adana Medical Park Seyhan Hastanesi ( Site 2407)Seyhan, Adana, Turkey (Türkiye)Reclutando
Hacettepe Universite Hastaneleri ( Site 2400)Altindağ, Ankara, Turkey (Türkiye)Reclutando
Gazi Universitesi Tip Fakultesi ( Site 2404)Ankara, Turkey (Türkiye)Reclutando
Ankara Bilkent Sehir Hastanesi ( Site 2401)Ankara, Turkey (Türkiye)Reclutando
Trakya Universitesi Tip Fakultesi ( Site 2406)Edirne, Turkey (Türkiye)Reclutando
Bakirkoy Dr. Sadi Konuk Training and Research Hospital ( Site 2408)Istanbul, Turkey (Türkiye)Reclutando
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2403)Istanbul, Turkey (Türkiye)Reclutando
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2405)Istanbul, Turkey (Türkiye)Reclutando
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)Chernivtsi, Chernivetska Oblast, UkraineReclutando
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)Lviv, Lviv Oblast, UkraineReclutando
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2518)Odesa, Odesa Oblast, UkraineReclutando
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)Rivne, Rivne Oblast, UkraineReclutando
Zhytomyr Regional Oncology Center ( Site 2519)Zhytomyr, Zhytomyr Oblast, UkraineReclutando
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)Kyiv, UkraineReclutando
Universal Clinic Oberig ( Site 2506)Kyiv, UkraineReclutando
Royal Cornwall Hospital ( Site 2614)Truro, Cornwall, United KingdomReclutando
Royal Free Hospital ( Site 2601)London, London, City of, United KingdomReclutando
Queen Elizabeth Hospital Birmingham ( Site 2612)Birmingham, United KingdomReclutando
Leicester Royal Infirmary ( Site 2610)Leicester, United KingdomReclutando
Equipo y fechas
- Patrocinador principal
- Merck Sharp & Dohme LLC
- Inicio del estudio
- 8 oct 2025 Real
- Finalización primaria
- 7 dic 2029 Estimado
- Finalización del estudio
- 6 ago 2032 Estimado
- Primera publicación
- 24 sept 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026
