ReclutandoNCT07431827Registro de ClinicalTrials.gov

MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

Non-small Cell Lung Cancer

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LO ESENCIAL

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: 400 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

This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.

¿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:

Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:

Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC
Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.
Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has active infection requiring systemic therapy
Has not adequately recovered from major surgery or has ongoing surgical complications

Entiende la evaluación inicial

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 triple

Calderasib + MK-3475A

Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.

Drug: Calderasib · Biological: MK-3475A

Placebo + MK-3475A

Participants receive placebo qd and MK-3475A q6w for up to 9 doses.

Biological: MK-3475A · Drug: Placebo

Calderasib DRUG

MK-1084 oral tablet

MK-3475A BIOLOGICAL

Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.

Placebo DRUG

Placebo oral tablet

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Disease-free Survival (DFS)

Plazo: Up to ~11 years

DFS is the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

Medidas secundarias

Overall Survival (OS)

Plazo: Up to ~11 years

OS is the time from randomization to death due to any cause.

Distant Metastasis-Free Survival (DMFS)

Plazo: Up to ~11 years

DMFS is the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

Lung Cancer Specific Survival (LCSS)

Plazo: Up to ~11 years

LCSS is the time from randomization to the date of death due to lung cancer.

Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

Plazo: Up to ~11 years

Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30).

Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

Plazo: Up to ~11 years

Change from baseline in physical functioning score (QLQ-C30 Items 1 to 5).

Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

Plazo: Up to ~11 years

Change from baseline in role functioning score (QLQ-C30 Items 6 and 7).

Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score

Plazo: Up to ~11 years

Change from baseline in dyspnea (QLQ-C30 Item 8).

Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score

Plazo: Up to ~11 years

Change from baseline in coughing scores (EORTC QLQ-LC24 Items 31 and 52).

Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score

Plazo: Up to ~11 years

Change from baseline in chest pain score (EORTC QLQ-LC24 Item 40).

Number of Participants Who Experience an Adverse Event (AE)

Plazo: Up to ~13.5 years

Number of participants with ≥1 AE.

Number of Participants Who Discontinue Study Treatment Due to an AE

Plazo: Up to ~13.5 years

Number of participants discontinuing from study therapy due to AE.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (122)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

Buscar un centro en este estudio

122 centros

Instituto Alexander Fleming ( Site 0310)Ciudad Autónoma de Buenos Aires, Buenos Aires, ArgentinaReclutando

Study CoordinatorCONTACT+541132218900

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (122)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research