Activo, sin reclutamientoNCT05816252Registro de ClinicalTrials.gov

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

Non-small Cell Lung Cancer

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

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: 356 Real

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

The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

Leer la descripción completa

This is a multicenter, open-label study of SKB264 as combination therapy or monotherapy in subjects with NSCLC. Approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.

¿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

1. Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender;
2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ;
3. Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation;
4. Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment;
5. Subjects are able to provide tumor blocks or slides before the first dose of study intervention;
6. Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria;
7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1;
8. Life expectancy at least 3 months for the subject;
9. Adequate organ function;
10. Subjects must have recovered from all toxicities led by prior treatment;
11. Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects;
12. Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion Criteria

1. Subjects with mixed SCLC histopathological features;
2. Subjects with a known history of prior malignancy;
3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases;
4. Subjects with ≥ Grade 2 peripheral neuropathy;
5. Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome;
6. Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease;
7. Subjects who suffer from cardiovascular diseases of clinical significance;
8. Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids;
9. Subjects with uncontrolled systemic disease as judged by the Investigator;
10. Subjects with active autoimmune disease that required systemic treatment in the past 2 years;
11. Subjects with active hepatitis B or hepatitis C;
12. Subjects with known history of Human Immunodeficiency Virus (HIV)
13. Subjects with known active tuberculosis;
14. Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;
16. Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention;
17. Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.

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

Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%

SKB264 (Dose Level 1) + Pembrolizumab

Drug: SKB264 · Drug: Pembrolizumab

Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level

SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin

Drug: SKB264 · Drug: Pembrolizumab · Drug: Carboplatin

Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level

SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin

Drug: SKB264 · Drug: Pembrolizumab · Drug: Carboplatin

Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy

SKB264 (Dose Level 1') + Carboplatin

Drug: SKB264 · Drug: Carboplatin

Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy

SKB264 (Dose Level 1'') + Carboplatin

Drug: SKB264 · Drug: Carboplatin

Cohort 7 1L NSCLC with EGFR mutation

SKB264 (Dose Level 1) + Osimertinib

Drug: SKB264 · Drug: Osimertinib

Cohort 7-1 1L NSCLC with EGFR mutation

SKB264 (Dose Level 2) + Osimertinib

Drug: SKB264 · Drug: Osimertinib

Cohort 9 2/3L NSCLC EGFR/ALK negative

SKB264 (Dose Level 1)

Drug: SKB264

SKB264 DRUG

intravenous (IV) infusion (Q2W or Q3W)

Pembrolizumab DRUG

intravenous (IV) infusion (400mg, Q6W)

Carboplatin DRUG

intravenous (IV) infusion (AUC5, Q3W)

Osimertinib DRUG

80mg, QD

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Safety and tolerability

Plazo: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months

Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs

ORR

Plazo: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months

Objective response rate (ORR) per RECIST v1.1

Medidas secundarias

Duration of response (DOR)

Plazo: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months

For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first

Progression-free survival (PFS)

Plazo: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months

The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first

Overall survival (OS)

Plazo: From baseline until death due to any cause, up to approximately 36 months

the time period from the start of study intervention to death due to any cause.

El registro no indica resultados publicados.

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

Abrir resultados oficiales ↗

Centros de investigación (50)

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

Buscar un centro en este estudio

50 centros

Beijing Cancer HospitalBeijing, Beijing Municipality, ChinaEstado desconocido

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 (50)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research