Estudio de fase 2 de MRTX849 en monoterapia y en combinación con pembrolizumab en pacientes con cáncer de pulmón no microcítico avanzado con mutación KRAS G12C.

Datos básicos

Código:: 849-007
Protocolo:: 849-007
EUDRACT:: 2020-003101-58
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:: 2022
Año de finalización:: 2024

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar la eficacia de MRTX849 en monoterapia y en combinación con pembrolizumab administrado en el contexto de tratamiento de primera línea a pacientes con CPNM con mutación de KRAS G12C. Objetivos Secundarios: -Caracterizar la seguridad y tolerabilidad de la monoterapia y la pauta combinada en la población seleccionada. -Evaluar los criterios de valoración secundarios de la eficacia utilizando la monoterapia y la pauta combinada en la población seleccionada. -Evaluar la farmacocinética (FC) de MRTX849 administrado en monoterapia y en combinación con pembrolizumab.

Documentos

No hay documentos

Participantes

Carmina Rodrigo Jarque

Data Manager / Study Coordinator
Irene Torres Espallardo

Investigador Colaborador
Nuria Mancheño Franch

Investigador Colaborador
Óscar José Juan Vidal

Investigador Principal
Francisco De Asís Aparisi Aparisi

Investigador Colaborador
Ana María Osa Sáez

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Lorena Jiménez Ramos

Data Manager / Study Coordinator
Cora Palanca Ballester

Data Manager / Study Coordinator
Begoña Martinez Sanchis

Investigador Colaborador
Sonia Gines Cardenas

Investigador Colaborador
Ana María Soler Garrigos

Investigador Colaborador
Africa Almendros Riaza

Investigador Colaborador
Fatima Tomas Medina

Investigador Colaborador
Oussama Bardouz Gouguasse

Investigador Colaborador
Silvia Maestro Huguet

Investigador Colaborador
Maria Del Mar San Juan Tubilleja

Investigador Colaborador
Elena Teijeiro Vazquez

Investigador Colaborador
Juan Genovés Monzó

Data Manager / Study Coordinator

Ver todos los Investigadores

Grupos

Investigación Clínica y Traslacional en Cáncer

Leader

José Gómez Codina
Grupo de Investigación Clínica y Traslacional en Cardiología

Investigador Principal

Esther Roselló Lletí
Farmacogenética

Investigador Principal

María José Herrero Cervera
Investigacion Biomédica en Imagen (GIBI 2-30)

Investigador Principal

Leonor Cerdá Alberich
Núcleo de investigación traslacional integrado Urológico de Valencia (NITIUV)

Leader

César David Vera Donoso
Unidad de Biomarcadores y Medicina de Precisión (UBYMP)

Leader

Agustín Lahoz Rodríguez
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

MIRATI THERAPEUTICS

Resultados del Ensayo Clínico

Publicaciones en Revistas 115

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CA125: a new biomarker in patients with Fontan circulation.

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Correction. 10.1007/s12094-023-03290-7. 2023

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Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.8560. 2024

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Letter. 10.1186/s40545-022-00475-3. 2022

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Suay, Guillermo; (...); Lahoz, Agustin

Review. 10.1016/j.canlet.2024.217317. 2024

Immunogenicity of COVID-19 vaccines in lung cancer patients.

Provencio M; (...); Calvo V

Article. 10.1016/j.lungcan.2023.107323. 2023

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Meeting Abstract. 10.1182/blood-2022-169938. 2022

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Article. 10.1016/j.farma.2023.11.008. 2024

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Meeting Abstract. 2022

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Poveda JL; (...); Badia X

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Review. 10.3390/biology12091159. 2023

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Meeting Abstract. 2024

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

Phase II Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated Brain Metastases (Atezo-Brain, GECP17/05).

Nadal E; (...); Bruna J

Article. 10.1200/JCO.22.02561. 2023

Plain language summary: tarlatamab for patients with previously treated small cell lung cancer.

Ahn, Myung-Ju; (...); Paz-Ares, Luis

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Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

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Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

Falkenhain-Lopez, D; (...); Ortiz-Romero, P L

Article. 10.1016/j.ad.2022.11.010. 2023

Quantitative evaluation of a non-CT based attenuation correction method for a new dedicated brain PET

Gandia-Ferrero, M.; (...); Marti-Bonmati, L.

Meeting Abstract. 2022

Radioembolization in patients with hepatocellular carcinoma: a series of 53 cases.

Olivan-Sasot, P; (...); Olivas-Arroyo, C

Article. 10.1016/j.rxeng.2021.03.001. 2023

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Meeting Abstract. 2023

Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.

Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis

Article. 10.1016/j.bbr.2023.114844. 2024

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Hernandez, S.; (...); Conde, E.

Meeting Abstract. 2022

Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study.

Paz-Ares, Luis G.; (...); Garassino, Marina Chiara

Meeting Abstract. 10.1200/JCO.2024.42.17_suppl.LBA8500. 2024

Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study.

Paz-Ares, Luis G.; (...); Garassino, Marina Chiara

Article. 10.1200/JCO.24.00733. 2024

Sacituzumab Govitecan vs Docetaxel in Patients with mNSCLC Non-responsive to Last Anti-PD-(L)1containing Regimen: EVOKE-01

Garassino, M. C.; (...); Paz-Ares, L. G.

Meeting Abstract. 2024

Second-line treatment in advanced non-squamous (NS) non-small cell lung cancer (NSCLC) patients in Spain, analyzed in the Thoracic Tumor Registry (RTT)

Carcereny Costa, E.; (...); Provencio Pulla, M.

Meeting Abstract. 10.1016/j.annonc.2022.02.062. 2022

Sex Differences in the Efficacy of Immune Checkpoint Inhibitors in Neoadjuvant Therapy of Non-Small Cell Lung Cancer: A Meta-Analysis

Suay, Guillermo; (...); Juan-Vidal, Oscar

Review. 10.3390/cancers15184433. 2023

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

Spatially Preserved Multi-Region Transcriptomic Subtyping and Biomarkers of Chemoimmunotherapy Outcome in Extensive-Stage Small Cell Lung Cancer.

Peressini M; (...); Zugazagoitia J

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Article. 10.1007/s00431-022-04628-z. 2022

The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

Gil-Nagel A; (...); Gil A

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Badia, Xavier; (...); Valles, Joan-Antoni

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Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

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Updated analysis from the ATEZO-BRAIN trial: Atezolizumab plus carboplatin and pemetrexed in patients with advanced nonsquamous non-small cell lung cancer with untreated brain metastases.

Nadal, Ernest; (...); Bruna, Jordi

Meeting Abstract. 2022

Utility of Next-Generation Sequencing in the Reconstruction of Clonal Architecture in a Patient with an EGFR Mutated Advanced Non-Small Cell Lung Cancer: A Case Report.

Simarro J; (...); Palanca S

Article. 10.3390/diagnostics12051266. 2022

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.

Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene

Article. 10.1007/s13246-024-01452-7. 2024