A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Non-Small-Cell Lung Carcinoma
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 1 / Fase 2
- Rango de edad
- 18 años - 130 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 212 Real
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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 I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
Leer la descripción completa
This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).
¿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:
- Written informed consent
- Aged 18 or above
- Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
- Documented PD-L1 expression by PD-L1 IHC per local report.
- Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
- Part C and Part D: No prior I/O treatment for metastatic NSCLC.
- Part E: No prior treatment for metastatic NSCLC.
- ECOG performance status of 0 or 1 at enrolment.
- Life expectancy of ≥ 12 weeks at enrolment.
- Have at least 1 measurable lesion per RECIST v1.1.
- Adequate bone marrow, liver and kidney function
Exclusion Criteria:
- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
- Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
- Previous treatment with an anti-TIGIT therapy
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
- Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).
Treatment with one previous systemic chemotherapy will be allowed.
- Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
- Symptomatic central nervous system (CNS) metastasis.
- Thromboembolic event within 3 months prior to enrolment.
- Other invasive malignancy within 2 years prior to screening.
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
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)
Rilvegostomig Intravenous (IV) monotherapy
Drug: AZD2936
Dose Expansion Part B: CPI experienced NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
Dose Expansion Part C: CPI Naive NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
Dose Expansion Part D: CPI Naive NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
Dose Expansion Part E: treatment Naive Squamous NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
AZD2936 DRUG
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
Plazo: Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Rate of rilvegostomig discontinuation due to toxicity
Plazo: Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)
Percentage of participants with AEs leading to discontinuation of rilvegostomig
Objective Response Rate (ORR)
Plazo: Part B, C, D and E: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)
Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1
Medidas secundarias
ORR
Plazo: Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Percentage of participants with a confirmed CR or PR according to RECIST v1.1
Disease control rate (DCR)
Plazo: Part A, B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment
Duration of response (DoR)
Plazo: Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression
Durable response rate (DRR)
Plazo: Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
The percentage of participants according to RECIST v1.1 with a confirmed CR or PR lasting 6 months or more
Progression-free survival (PFS)
Plazo: Part B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Plazo: Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B.
Evaluation of the target engagement of rilvegostomig in peripheral blood
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Plazo: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Maximum observed plasma concentration of rilvegostomig
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Plazo: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Area under the plasma concentration-time curve
PK of rilvegostomig: Clearance
Plazo: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
A pharmacokinetic measurement of the volume of plasma from which the study intervention is completely removed per unit time.
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Plazo: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Terminal elimination half life
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Plazo: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Immunogenicity of rilvegostomig
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (40)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
40 centros
Research SiteChicago, Illinois, United StatesEstado desconocido
Research SiteRochester, Minnesota, United StatesEstado desconocido
Research SiteFairfax, Virginia, United StatesEstado desconocido
Research SiteMelbourne, AustraliaEstado desconocido
Research SiteAnderlecht, BelgiumEstado desconocido
Research SiteLeuven, BelgiumEstado desconocido
Research SiteFlorianópolis, BrazilEstado desconocido
Research SiteNatal, BrazilEstado desconocido
Research SitePorto Alegre, BrazilEstado desconocido
Research SiteRio de Janeiro, BrazilEstado desconocido
Research SiteSão Paulo, BrazilEstado desconocido
Research SiteChengdu, ChinaEstado desconocido
Research SiteChongqing, ChinaEstado desconocido
Research SiteCopenhagen, DenmarkEstado desconocido
Research SiteDijon, FranceEstado desconocido
Research SiteToulouse, FranceEstado desconocido
Research SiteTbilisi, GeorgiaEstado desconocido
Research SiteKashiwa, JapanEstado desconocido
Research SiteNiigata, JapanEstado desconocido
Research SiteSendai, JapanEstado desconocido
Research SiteTokyo, JapanEstado desconocido
Research SiteKuala Lumpur, MalaysiaEstado desconocido
Research SiteKuching, MalaysiaEstado desconocido
Research SiteChisinau, MoldovaEstado desconocido
Research SiteGroningen, NetherlandsEstado desconocido
Research SiteLeiden, NetherlandsEstado desconocido
Research SiteUtrecht, NetherlandsEstado desconocido
Research SiteSeoul, South KoreaEstado desconocido
Research SiteSeoul, South KoreaEstado desconocido
Research SiteSeoul, South KoreaEstado desconocido
Research SiteBarcelona, SpainEstado desconocido
Research SiteMadrid, SpainEstado desconocido
Research SiteMadrid, SpainEstado desconocido
Research SiteTaichung, TaiwanEstado desconocido
Research SiteTaichung, TaiwanEstado desconocido
Research SiteTainan, TaiwanEstado desconocido
Research SiteTaipei, TaiwanEstado desconocido
Research SiteBangkok, ThailandEstado desconocido
Research SiteChanthaburi, ThailandEstado desconocido
Research SiteMuang, ThailandEstado desconocido
Equipo y fechas
- Patrocinador principal
- AstraZeneca
- Inicio del estudio
- 14 sept 2021 Real
- Finalización primaria
- 1 jun 2028 Estimado
- Finalización del estudio
- 1 jun 2028 Estimado
- Primera publicación
- 9 ago 2021 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026