ReclutandoNCT06868485Registro de ClinicalTrials.gov

A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

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 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 40 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 II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

Leer la descripción completa

WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.

¿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:

Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
Male or female aged ≥18 years old.
Histological or cytological confirmation diagnosis of NSCLC.
Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
Documented EGFR mutation .
Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
At least one lesion, not previously irradiated and not chosen for biopsy during the study.
Females should have evidence of non-childbearing potential.

Exclusion criteria:

Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
Symptomatic brain complications that require urgent neurosurgical or medical intervention.
Any evidence of severe or uncontrolled systemic diseases.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
Past medical history of ILD.
Inadequate bone marrow reserve or organ function as demonstrated.
Males and females of reproductive potential.
Known intracranial hemorrhage which is unrelated to tumor.
Seizures requiring a change in anti-epileptic medications.

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: Sin enmascaramiento

Dose level A selected from Phase I study

BID

Drug: WSD0922-FU Tablets, Dose level A

Dose level B selected from Phase I study

BID

Drug: WSD0922-FU Tablets, Dose level B

WSD0922-FU Tablets, Dose level A DRUG

Oral, 21 days in each cycle

WSD0922-FU Tablets, Dose level B DRUG

Oral, 21 days in each cycle

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

ORR

Plazo: every 8 weeks, up to 1 year

proportion of patients with a best overall response of complete response or partial response

Medidas secundarias

Duration of Response (DoR)

Plazo: every 8 weeks, up to 1 year

proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression

PFS

Plazo: every 8 weeks, up to 1 year

proportion of patients with the time from randomization until the date of objective disease progression or death

Disease Control Rate (DCR)

Plazo: every 8 weeks, up to 1 year

the percentage of patients who have a best overall response of CR or PR or SD

Overall Survival (OS)

Plazo: 24 months

the time from the date of randomization until death due to any cause

EORTC QLQ-C30 (HRQoL)

Plazo: up to 24 months

PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated.

EORTC QLQ-LC13 (HRQoL)

Plazo: up to 24 months

PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated.

PRO CTCAE (HRQoL)

Plazo: up to 24 months

To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated.

El registro no indica resultados publicados.

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

Abrir resultados oficiales ↗

Centros de investigación (16)

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

Buscar un centro en este estudio

16 centros

Cleveland Clinic Weston HospitalWeston, Florida, United StatesReclutando

Principal InvestigatorCONTACTsaravid@ccf.org 866-293-7866

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 (16)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research