Un estudio de seguridad y eficacia de EIK1001 en combinación con pembrolizumab y quimioterapia en participantes con cáncer de pulmón de células no pequeñas en estadio 4. (TeLuRide-008)
Un estudio global, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de fase 2/3 de EIK1001 en combinación con pembrolizumab y quimioterapia en participantes con cáncer de pulmón de células no pequeñas en estadio 4 (TeLuRide-008).
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
Descripción general del estudio
Estado
Descripción detallada
This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elelta Shiferraw
- Número de teléfono: 314-209-3659
- Correo electrónico: shiferrawe@eikontx.com
Ubicaciones de estudio
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Hamburg, Alemania, 22087
- Reclutamiento
- Katholische Marienkrankenhaus gGmbH
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Saxony
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Dresden, Saxony, Alemania, 01307
- Reclutamiento
- University Hospital Carl Gustav Carus Dresden
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New South Wales
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Frenchs Forest, New South Wales, Australia, 2086
- Reclutamiento
- Cancer Care Northern Beaches
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Waratah, New South Wales, Australia, 2298
- Reclutamiento
- Calvary Mater Newcastle Hospital
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Victoria
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Frankston, Victoria, Australia, 3199
- Reclutamiento
- Peninsula and Southeast Oncology (PASO) Medical
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Saint Albans, Victoria, Australia, 3021
- Reclutamiento
- Sunshine Hospital - Western Health
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Linz, Austria, 4020
- Reclutamiento
- Kepler Universitaetsklinikum
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasil, 29308-065
- Reclutamiento
- Hospital Evangélico de Cachoeiro de Itapemirim
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40170-110
- Reclutamiento
- Nucleo de Oncologia da Bahia
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasil, 22250-905
- Reclutamiento
- Oncoclinicas Rio de Janeiro
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Brussels, Bélgica, 1020
- Reclutamiento
- Centre Hospitalier Universitaire Brugmann
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Daegu
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Daegu, Daegu, Corea del Sur, 42415
- Reclutamiento
- Yeungnam University College of Medicine
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Incheon Gwang'Yeogsi
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Incheon, Incheon Gwang'Yeogsi, Corea del Sur, 21565
- Reclutamiento
- Gachon University - Gil Medical Center
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Jeollanam-do
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Hwasun, Jeollanam-do, Corea del Sur, 58128
- Reclutamiento
- Chonnam National University Hwasun Hospital (CNUHH)
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Barcelona, España, 08028
- Reclutamiento
- Instituto Oncologico Dr. Rosell (IOR)
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Girona, España, 17007
- Reclutamiento
- Institut Catala D'Oncologia de Girona
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Málaga, España, 29004
- Reclutamiento
- Hospital Quirónsalud Málaga
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Cadiz
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Jerez de la Frontera, Cadiz, España, 11407
- Reclutamiento
- Hospital Universitario de Jerez de la Frontera
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Castellón
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Castellon, Castellón, España, 12006
- Reclutamiento
- Consorci Hospitalari Provincial de Castello
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Malaga
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Málaga, Malaga, España, 29011
- Reclutamiento
- Hospital Regional Universitario de Malaga
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Alabama
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Daphne, Alabama, Estados Unidos, 36526
- Reclutamiento
- Southern Cancer Center, P.C.
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California
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Glendale, California, Estados Unidos, 91204
- Reclutamiento
- Los Angeles Cancer Network
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Orange, California, Estados Unidos, 92868
- Reclutamiento
- Providence St. Joseph Hospital
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Colorado
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Pueblo, Colorado, Estados Unidos, 81103
- Reclutamiento
- Rocky Mountain Cancer Centers, LLP
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Florida
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Doral, Florida, Estados Unidos, 33172
- Reclutamiento
- Omnicure Clinical Research
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Plantation, Florida, Estados Unidos, 33322
- Reclutamiento
- Florida Clinical Trials Group
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Tamarac, Florida, Estados Unidos, 33321
- Reclutamiento
- Florida Clinical Trials Group - Tamarac
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Illinois
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Peoria, Illinois, Estados Unidos, 61637
- Reclutamiento
- OSF Saint Francis Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Reclutamiento
- University of New Mexico - Comprehensive Cancer Center
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New York
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Mineola, New York, Estados Unidos, 11501
- Reclutamiento
- NYU Langone Hospital Long Island
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New York, New York, Estados Unidos, 10016
- Reclutamiento
- NYU Langone Hospital Manhattan
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The Bronx, New York, Estados Unidos, 10461
- Reclutamiento
- Jacobi Medical Center - Albert Einstein College of Medicine
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White Plains, New York, Estados Unidos, 10601
- Reclutamiento
- White Plains Hospital
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Tennessee Oncology
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Texas
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Fort Worth, Texas, Estados Unidos, 76104
- Reclutamiento
- The Center for Cancer and Blood Disorders
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Virginia
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Blacksburg, Virginia, Estados Unidos, 24060
- Reclutamiento
- Blue Ridge Cancer Center
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Fairfax, Virginia, Estados Unidos, 22031
- Reclutamiento
- Virginia Cancer Specialists, PC
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Winchester, Virginia, Estados Unidos, 22601
- Reclutamiento
- Shenandoah Oncology P.C.
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Athens, Grecia, 11516
- Reclutamiento
- Henry Dunant Hospital Center
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 31-864
- Reclutamiento
- GCPMED Sp. z o.o., Centrum Medyczne iMed24
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Gauteng
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Saxonwold, Gauteng, Sudáfrica, 2196
- Reclutamiento
- The Medical Oncology Centre of Rosebank
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Western Cape
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George, Western Cape, Sudáfrica, 6529
- Reclutamiento
- Task Eden
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
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Participant must be ≥ 18 years old at the time of signing the informed consent.
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Participant has a life expectancy of at least 3 months.
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Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
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Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
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Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
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Participant has not received prior systemic therapy for advanced/metastatic NSCLC.
Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.
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Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
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Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is < 3yrs old).
Key Exclusion Criteria:
- has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
- is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
- has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
- has received a live-virus vaccination within 30 days of the start of study intervention initiation.
- has received radiation therapy within 7 days of the first dose of study intervention administration.
- has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC). |
Placebo control PD-1 inhibitor SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for non-squamous NSCLC |
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Experimental: Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC). |
PD-1 inhibitor SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for non-squamous NSCLC EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist |
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Experimental: Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC). |
PD-1 inhibitor SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for non-squamous NSCLC EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression-free survival (PFS)
Periodo de tiempo: Through study completion, up to 6 years
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Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first |
Through study completion, up to 6 years
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Overall survival (OS)
Periodo de tiempo: Through study completion, up to 10 years
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OS defined as the time from the first dose of study medication to death due to any cause |
Through study completion, up to 10 years
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Objective Response (OR)
Periodo de tiempo: Through study completion, up to 6 years
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Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only). |
Through study completion, up to 6 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Objective response (OR)
Periodo de tiempo: Up to 6 years
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Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR |
Up to 6 years
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Duration of response (DOR)
Periodo de tiempo: Up to 6 years
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DOR 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, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR. |
Up to 6 years
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Progression-free survival (PFS) by Investigator
Periodo de tiempo: Up to 6 years
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Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by Investigator, or death due to any cause, whichever occurs first. |
Up to 6 years
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Overall Response Rate (ORR) by Investigator
Periodo de tiempo: Up to 6 years
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Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator. |
Up to 6 years
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Duration of Response (DOR) by Investigator
Periodo de tiempo: Up to 6 years
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DOR 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, in participants demonstrating CR or PR, according to RECIST 1.1 by Investigator. |
Up to 6 years
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Incidence of Adverse Events (AEs)
Periodo de tiempo: Up to 2.5 years
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Adverse Events (AEs) and discontinuation of study treatment due to any AE. |
Up to 2.5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Nishitha Reddy, Eikon Therapeutics
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células no pequeñas
- Aminoácidos, péptidos y proteínas
- Químicos orgánicos
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Químicos inorgánicos
- Compuestos de cloro
- Compuestos de nitrógeno
- Complejos de coordinación
- Guanina
- Hipoxantino
- Purinones
- Purinas
- Glutamatos
- Aminoácidos, ácido
- Aminoácidos
- Aminoácidos, dicarboxílico
- Compuestos de platino
- Pemetrexed
- Carboplatino
- Cisplatino
- pembrolizumab
- Paclitaxel de 130 nm en albúmina
- Protocolo CP
Otros números de identificación del estudio
- EIK1001-008
- 2025-525013-23-00 (Ctis)
- KEYNOTE-G57 (Otro identificador: Merck Sharp & Dohme LLC)
- MK-3475-G57 (Otro identificador: Merck Sharp & Dohme LLC)
- 2025 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .