Um estudo de quimioterapia Cemiplimabe Plus versus quimioterapia Cemiplimabe Plus mais outros tratamentos de câncer para pacientes adultos com câncer de pulmão de células não pequenas operável (NSCLC)
Um estudo randomizado de plataforma de fase 2 para avaliar quimioterapia Cemiplimabe Plus versus quimioterapia Cemiplimabe Plus mais outros tratamentos de câncer para o tratamento perioperatório de pacientes com câncer de pulmão de células não pequenas ressecável
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.
The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."
The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.
For the resectable NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the investigational treatments in comparison to the control treatment
- Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
- How much of the study drug(s) are in the blood at a given time
- Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
- How does the additional drug work in combination with cemiplimab and chemotherapy
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
-
Aachen, Alemanha, 52074
- University Hospital RWTH Aachen
-
-
Hesse
-
Kassel, Hesse, Alemanha, 34125
- Klinikum Kassel GmbH, Hauttumorzentrum
-
-
Lower Saxony
-
Göttingen, Lower Saxony, Alemanha, 37083
- University Medicine Gottingen
-
-
Saxony
-
Leipzig, Saxony, Alemanha, 04103
- University of Leipzig
-
-
-
-
-
São Paulo, Brasil, 01323-903
- Hospital Alemao Oswaldo Cruz
-
-
Espírito Santo
-
Cachoeiro de Itapemirim, Espírito Santo, Brasil, 29306014
- Oncology Clinical Research Center
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasil, 30380-472
- Instituto Mario Penna
-
Pouso Alegre, Minas Gerais, Brasil, 37554-238
- Instituto Sul Mineiro De Oncologia LTDA
-
-
Pernambuco
-
Recife, Pernambuco, Brasil, 50070-902
- Instituto de Medicina Integral Professor Fernando Figueira
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brasil, 59060-195
- Liga Norte Riograndense Contra o Cancer
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
- Hospital Sao Lucas da PUCRS
-
Porto Alegre, Rio Grande do Sul, Brasil, 90110-270
- Hospital Mae de Deus Integrated Oncology Center
-
-
Santa Catarina
-
Florianópolis, Santa Catarina, Brasil, 88020-210
- Ynova Pesquisa Clinica
-
-
São Paulo
-
Sorocaba, São Paulo, Brasil, 18065-100
- Unimed Sorocaba
-
São José do Rio Preto, São Paulo, Brasil, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
-
-
-
-
-
Madrid, Espanha, 28046
- Hospital Universitario La Paz
-
Madrid, Espanha, 28040
- Hospital Universitario Clinico San Carlos
-
Madrid, Espanha, 28033
- MD Anderson Cancer Center
-
Madrid, Espanha, 28050
- Hospital Universitario HM Sanchinarro
-
Seville, Espanha, 41013
- Hospital Virgen del Rocio
-
Valencia, Espanha, 46014
- Consorci Hospital General Universitario de Valencia
-
Valencia, Espanha, 46010
- Hospital Clinico Universitario Valencia
-
Zaragoza, Espanha, 50009
- Hospital Clinico Lozano Blesa
-
-
Barcelona
-
Badalona, Barcelona, Espanha, 08916
- Catalan Instituye of Oncology Badalona
-
-
Cantabria
-
Santander, Cantabria, Espanha, 39008
- Hospital Valdecilla
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Espanha, 35016
- Hospital Universitario Insular de Gran Canaria
-
-
Navarre
-
Pamplona, Navarre, Espanha, 31008
- Clinica Universidad de Navarra
-
-
-
-
California
-
Orange, California, Estados Unidos, 92868
- University of California Irvine
-
-
Illinois
-
Skokie, Illinois, Estados Unidos, 60077
- Orchard Healthcare Research Inc.
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
-
Farmington Hills, Michigan, Estados Unidos, 48334
- Detroit Clinical Research Center
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45245
- Oncology Hematology Care Clinical Trials LLC
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Estados Unidos, 97213
- University Of Nebraska Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02903
- Lifespan Cancer Institute
-
-
South Dakota
-
Watertown, South Dakota, Estados Unidos, 57201
- Prairie Lakes Healthcare System
-
-
Tennessee
-
Knoxville, Tennessee, Estados Unidos, 37920
- University of Tennessee Medical Center
-
Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
-
-
Virginia
-
Blacksburg, Virginia, Estados Unidos, 24060
- BRCC/Oncology & Hematology Associates of SW Virginia
-
-
-
-
-
Bayonne, França, 64100
- Clinique Belharra
-
Bayonne, França, 64100
- Centre Hospitalier de la Cote Basque
-
Grenoble, França, 38330
- CHU Grenoble Alpes
-
Montpellier, França, 34295
- Montpellier Academic Hospital
-
-
Brittany Region
-
Rennes, Brittany Region, França, 35033
- CHU Rennes
-
-
Var
-
Toulon, Var, França, 83055
- Centre Hospitalier Intercommunal Toulon - CHITS
-
-
Île-de-France Region
-
Paris, Île-de-France Region, França, 75005
- Institut Curie
-
-
-
-
-
Istanbul, Turquia (Türkiye), 34295
- Florya Medical Park Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:
- Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
- Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
- Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
- Adequate organ and bone marrow function, as described in the protocol
Arm Specific Inclusion Criteria:
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
- Availability of an archival or on-trial FFPE tumor tissue sample
- ECOG performance status of 0 or 1
- Per investigator judgment, life expectancy of at least 3 months
Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:
- Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
- Presence of grade≥ 2 peripheral neuropathy
- Another malignancy that is progressing or requires active treatment, as described in the protocol
Arm Specific Exclusion Criteria:
Neoadjuvant Resectable NSCLC - Arm 1:
- Grade ≥3 hypercalcemia, as defined in the protocol
- Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
- Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
- Known allergy or hypersensitivity to any components of trial interventions
- Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol
Neoadjuvant Resectable NSCLC - Arm 2:
1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Neoadjuvant Resectable NSCLC - Control Arm
|
Administered per the protocol
Outros nomes:
Administered per the protocol |
|
Experimental: Neoadjuvant Resectable NSCLC - Arm 1
|
Administered per the protocol
Outros nomes:
Administered per the protocol
Outros nomes:
Administered per the protocol |
|
Experimental: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
|
Administered per the protocol
Outros nomes:
Administered per the protocol Administered per the protocol
Outros nomes:
|
|
Experimental: Neoadjuvant Resectable NSCLC - Arm 2
|
Administered per the protocol
Outros nomes:
Administered per the protocol Administered per the protocol
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Prazo: Up to 12 weeks
|
Up to 12 weeks
|
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Prazo: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to death
Prazo: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to treatment discontinuation
Prazo: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of Serious Adverse Events (SAEs)
Prazo: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of grade ≥3 laboratory abnormalities
Prazo: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 9 weeks
|
|
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
Prazo: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sobrevivência geral (OS)
Prazo: Até 5 anos
|
Até 5 anos
|
|
|
Gravidade dos TEAEs
Prazo: Até 76 semanas
|
Até 76 semanas
|
|
|
Proporção de cirurgias atrasadas devido a TEAEs
Prazo: Até 76 semanas
|
Até 76 semanas
|
|
|
Proporção de cirurgias canceladas por TEAEs
Prazo: Até 76 semanas
|
Até 76 semanas
|
|
|
Pathologic Complete Response (pCR) rate as determined by central BIPR
Prazo: Up to 12 weeks
|
Up to 12 weeks
|
|
|
Residual Viable Tumor (RVT) as determined by central BIPR
Prazo: Up to 12 weeks
|
Up to 12 weeks
|
|
|
Event-Free Survival (EFS)
Prazo: Up to 5 years
|
Up to 5 years
|
|
|
Objective Response by investigator assessment
Prazo: Up to 9 weeks
|
Up to 9 weeks
|
|
|
Duration of Response (DoR) by investigator assessment
Prazo: Up to 2 years
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 2 years
|
|
Occurrence of TEAEs
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to death
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to treatment discontinuation
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of SAEs
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of SAEs
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Adverse Events of Special Interest (AESIs)
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of AESIs
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of immune-mediated Adverse Events (imAEs)
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of imAEs
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Infusion-Related Reactions (IRRs)
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of IRRs
Prazo: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of grade ≥3 laboratory abnormalities
Prazo: Up to 76 weeks
|
As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 76 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
Prazo: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to cemiplimab
Prazo: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to marlotamig
Prazo: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to marlotamig
Prazo: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to REGN10597
Prazo: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to REGN10597
Prazo: Up to 67 weeks
|
Up to 67 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Clinical Trial Management, Regeneron Pharmaceuticals
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- NSCLC
- Ressecção cirúrgica
- Câncer de pulmão em estágio inicial
- Carcinoma pulmonar de células não pequenas
- NSCLC ressecável
- Cirurgia de câncer de pulmão
- Carcinoma pulmonar de células não pequenas
- Carcinoma Pulmonar
- Early-stage non-small cell lung cancer
- Neoadjuvant NSCLC
- Operable non-small cell lung cancer
- Preoperative NSCLC
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R2810-ONC-2268
- 2023 (Concessão/Contrato do NIH dos EUA)
- 2023-509806-31-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Prazo de Compartilhamento de IPD
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
Critérios de acesso de compartilhamento IPD
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .