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Estudo para avaliar a segurança e eficácia de AZD2936 em participantes com câncer de pulmão de células não pequenas avançado ou metastático (ARTEMIDE-01)

9 de novembro de 2026 atualizado por: AstraZeneca

Fase I/II, aberto, escalonamento de dose e estudo de expansão de dose para avaliar a segurança, farmacocinética, farmacodinâmica e eficácia do anticorpo anti-TIGIT/anti-PD-1 AZD2936 em participantes com câncer de pulmão de células não pequenas avançado ou metastático

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Real)

212

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Melbourne, Austrália, 3000
        • Research Site
      • Florianópolis, Brasil, 88034-000
        • Research Site
      • Natal, Brasil, 59075-740
        • Research Site
      • Porto Alegre, Brasil, 90035903
        • Research Site
      • Rio de Janeiro, Brasil, 20231-050
        • Research Site
      • São Paulo, Brasil, 01246-000
        • Research Site
      • Anderlecht, Bélgica, 1070
        • Research Site
      • Leuven, Bélgica, 3000
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chongqing, China, 400030
        • Research Site
      • Seoul, Coréia do Sul, 03722
        • Research Site
      • Seoul, Coréia do Sul, 05505
        • Research Site
      • Seoul, Coréia do Sul, 03082
        • Research Site
      • Copenhagen, Dinamarca, 2100
        • Research Site
      • Barcelona, Espanha, 08035
        • Research Site
      • Madrid, Espanha, 28041
        • Research Site
      • Madrid, Espanha, 28027
        • Research Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Research Site
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Research Site
      • Dijon, França, 21079
        • Research Site
      • Toulouse, França, 31059
        • Research Site
      • Tbilisi, Geórgia, 0112
        • Research Site
      • Groningen, Holanda, 9713 GZ
        • Research Site
      • Leiden, Holanda, 2333 ZA
        • Research Site
      • Utrecht, Holanda, 3584 CX
        • Research Site
      • Kashiwa, Japão, 227-8577
        • Research Site
      • Niigata, Japão, 951-8566
        • Research Site
      • Sendai, Japão, 981-0914
        • Research Site
      • Tokyo, Japão, 104-0045
        • Research Site
      • Kuala Lumpur, Malásia, 59100
        • Research Site
      • Kuching, Malásia, 93586
        • Research Site
      • Chisinau, Moldávia, MD-2025
        • Research Site
      • Bangkok, Tailândia, 10700
        • Research Site
      • Chanthaburi, Tailândia, 22000
        • Research Site
      • Muang, Tailândia, 50200
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40201
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 110
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 130 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)

Rilvegostomig Intravenous (IV) monotherapy

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Outros nomes:
  • Rilvegostomig
Experimental: Dose Expansion Part B: CPI experienced NSCLC

Rilvegostomig IV monotherapy

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Outros nomes:
  • Rilvegostomig
Experimental: Dose Expansion Part C: CPI Naive NSCLC

Rilvegostomig IV monotherapy

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Outros nomes:
  • Rilvegostomig
Experimental: Dose Expansion Part D: CPI Naive NSCLC

Rilvegostomig IV monotherapy

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Outros nomes:
  • Rilvegostomig
Experimental: Dose Expansion Part E: treatment Naive Squamous NSCLC

Rilvegostomig IV monotherapy

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Outros nomes:
  • Rilvegostomig

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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.

Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig
Rate of rilvegostomig discontinuation due to toxicity
Prazo: 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

Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)
Objective Response Rate (ORR)
Prazo: 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

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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
ORR
Prazo: 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

Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Disease control rate (DCR)
Prazo: 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

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).
Duration of response (DoR)
Prazo: 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

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).
Durable response rate (DRR)
Prazo: 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

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).
Progression-free survival (PFS)
Prazo: 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

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).
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Prazo: 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

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.
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Prazo: 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

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.
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Prazo: 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

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.
PK of rilvegostomig: Clearance
Prazo: 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.

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.
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Prazo: 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

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.
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Prazo: 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

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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

14 de setembro de 2021

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

16 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2021

Primeira postagem (Real)

9 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • D7020C00001
  • 2021-000857-23 (Número EudraCT)
  • 2023-508262-15-00 (Identificador de registro: EU CT Number)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Prazo de Compartilhamento de IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level datain an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .