ReclutandoNCT07099898Registro de ClinicalTrials.gov

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]

Neoplasms, Lung

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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: 420 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

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.

¿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:

Participants are eligible to be included in the study only if all of the following criteria apply:

Adults \>18 or the minimum legal adult age at the time the informed consent form is signed
Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.
Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
Has adequate organ function and an ECOG performance status of 0 or 1

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Pathological diagnosis of complex SCLC or transformed SCLC.
Limited stage small cell lung cancer at diagnosis
Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.
Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Has severe, uncontrolled or active cardiovascular disorders.
Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.
Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids.
Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease),
Has active Hepatitis B or Hepatitis C

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

Risvutatug rezetecan (Ris-Rez)

No informado en este registro.

Biological: Risvutatug rezetecan (Ris-Rez)

Topotecan

No informado en este registro.

Drug: Topotecan

Risvutatug rezetecan (Ris-Rez) BIOLOGICAL

Ris-Rez will be administered

Topotecan DRUG

Topotecan will be administered

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Overall Survival (OS)

Plazo: Up to approximately 113 weeks

OS is defined as the time from the date of randomization to the date of death by any cause

Medidas secundarias

Brain PFS

Plazo: Up to approximately 139 weeks

Brain PFS is defined as the time from the date of randomization to the date of first documented PD per modified Response assessment in neuro-oncology (RANO-BM) by BICR assessment or death from any cause, whichever occurs first in participants with history of brain metastasis or presence of brain metastasis at baseline

Change from baseline in cough

Plazo: Up to approximately 18 weeks

Validated questionnaires will be used for the assessment

Change from baseline in dyspnea

Plazo: Up to approximately 18 weeks

Validated questionnaires will be used for the assessment

Change from baseline in chest pain

Plazo: Up to approximately 18 weeks

Validated questionnaires will be used for the assessment

Time to clinical deterioration in physical functioning

Plazo: Up to approximately 139 weeks

Time to clinical deterioration in physical functioning will be measured using validated questionnaires

Objective Response Rate (ORR)

Plazo: Up to approximately 139 weeks

ORR is defined as the percentage of participants with a confirmed complete (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator/Blinded Independent Central Review (BICR) assessment

Duration of Response (DoR)

Plazo: Up to approximately 139 weeks

DoR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator/BICR assessment to the date of first documented PD per RECIST 1.1 by investigator/BICR assessment or death due to any cause, whichever comes first

Progression-free survival (PFS)

Plazo: Up to approximately 139 weeks

PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by investigator/BICR assessment or death from any cause, whichever occurs first

Disease control rate (DCR) 12

Plazo: Up to approximately 11 weeks

DCR12 is defined as the percentage of participants who have a Best objective response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD) for a duration of at least 11 weeks, per RECIST 1.1 by investigator/BICR assessment

Brain DoR

Plazo: Up to approximately 139 weeks

Brain DoR is defined as the time from the first documented objective response (CR/PR according to modified RANO-BM BICR assessment) until the time of first documentation of disease progression or death, whichever occurs first, in participants with a history of brain metastasis or presence of brain metastasis at baseline

Brain ORR

Plazo: Up to approximately 139 weeks

Brain ORR is defined as the percentage of participants with confirmed brain CR or confirmed brain PR per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline

Brain DCR12

Plazo: Up to approximately 11 weeks

Brain DCR12 is defined as the percentage of participants with an intracranial BOR of confirmed CR, confirmed PR or SD after the date of randomization, per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline

Time to brain progression

Plazo: Up to approximately 139 weeks

Time to brain progression is defined as the time from the date of randomization to the date of first documented brain PD per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline.

Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity

Plazo: Up to approximately 139 weeks

No informado en este registro.

Number of participants with AEs leading to dose modifications or study intervention discontinuation

Plazo: Up to approximately 139 weeks

No informado en este registro.

Number of participants with a change from baseline in vital signs

Plazo: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)

Plazo: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)

Plazo: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status

Plazo: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Observed PK concentrations of Ris-Rez (conjugated antibody and small molecule payload)

Plazo: Up to approximately 139 weeks

No informado en este registro.

Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)

Plazo: Up to approximately 139 weeks

No informado en este registro.

Titers of ADA against Ris-Rez

Plazo: Up to approximately 139 weeks

No informado en este registro.

Participant reported experience with study treatment

Plazo: Up to approximately 139 weeks

Participant reported outcomes assessing symptoms, daily functioning, and overall health status during study treatment will be measured using validated questionnaires

El registro no indica resultados publicados.

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

Abrir resultados oficiales ↗

Centros de investigación (148)

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Buscar un centro en este estudio

148 centros

GSK Investigational SiteLos Angeles, California, United StatesReclutando

US GSK Clinical Trials Call CenterCONTACTGSKClinicalSupportHD@gsk.com 877-379-3718

EU GSK Clinical Trials Call CentreCONTACTGSKClinicalSupportHD@gsk.com +44 (0) 20 8990 4466

Ghassan Al-JazayrlyPRINCIPAL_INVESTIGATOR

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 (148)

Equipo y fechas

Contactos oficiales del estudio

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