Um estudo da terapia combinada com amivantamab e cetrelimab em participantes com câncer de pulmão metastático de células não pequenas (PolyDamas)
Um estudo de fase 1/2 avaliando a segurança e a eficácia da terapia combinada de amivantamab e cetrelimab no câncer de pulmão metastático de células não pequenas
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC characterized on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Barretos, Brasil, 14784 400
- Fundacao Pio XII
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Belo Horizonte, Brasil, 30110 022
- Cetus Oncologia
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Belo Horizonte, Brasil, 30130 090
- PERSONAL Oncologia de Precisao e Personalizada
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Curitiba, Brasil, 80810 050
- CIONC Centro Integrado de Oncologia de Curitiba
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Londrina, Brasil, 86015 520
- Hospital do Cancer de Londrina
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Porto Alegre, Brasil, 91350 200
- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brasil, 40050-410
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Alicante, Espanha, 03010
- Hosp. Gral. Univ. de Alicante
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Barcelona, Espanha, 8028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Espanha, 08035
- Hosp Univ Vall D Hebron
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Madrid, Espanha, 28041
- Hosp. Univ. 12 de Octubre
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Seville, Espanha, 41009
- Hosp. Virgen Macarena
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Valencia, Espanha, 46009
- Instituto Valenciano de Oncologia
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope
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Irvine, California, Estados Unidos, 92618
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Alamitos, California, Estados Unidos, 90720
- Cancer and Blood Specialty Clinic
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Providence Portland Medical Center
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Portland, Oregon, Estados Unidos, 97225
- Providence Oncology and Hematology Care Clinic Westside
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Texas
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Virginia Cancer Specialists
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Milan, Itália, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Milan, Itália, 20141
- European Institute of Oncology
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Orbassano, Itália, 10043
- Aou San Luigi Gonzaga
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Verona, Itália, 37134
- Centro Ricerche Cliniche di Verona S r l
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Kuala Lumpur, Malásia, 59100
- University Malaya Medical Centre
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Kuching, Malásia, 93586
- Hospital Umum Sarawak
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Lublin, Polônia, 20 609
- INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
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Poznan, Polônia, 60 569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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Warsaw, Polônia, 02 781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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London, Reino Unido, W6 8RF
- Imperial College London and Imperial College Healthcare NHS Trust
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Newcastle, Reino Unido, NE7 7DN
- Freeman Hospital
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Sutton, Reino Unido, SM2 5PT
- Royal Marsden Hospital
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Adana, Turquia (Türkiye), 01170
- Adana City Hospital
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Ankara, Turquia (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Ankara, Turquia (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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Ankara, Turquia (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi 1
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Istanbul, Turquia (Türkiye), 34147
- Bakirkoy Sadi Konuk Training and Research Hospital
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Istanbul, Turquia (Türkiye), 34722
- Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
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Izmir, Turquia (Türkiye), 35170
- Medicana International Izmir
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Sakarya, Turquia (Türkiye), 54100
- Sakarya Universitesi Egitim Ve Arastırma Hastanesi
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of enrollment: Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed on or after standard of care systemic anti-cancer therapy and participant is declining other systemic treatment options, if any;1. Participants without known mutations must have had disease progression on, or have intolerance to, prior platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or sequentially, OR 2. Participants with NSCLC characterized by known driver mutations must have had disease progression on, or have intolerance to, appropriate targeted therapies as per local standard of care. Participants may have received prior therapy with amivantamab as long as discontinuation was not due to toxicity. Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy, Phase 2 Expansion Cohorts; Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must have tumors lacking known primary driver mutations and must have PD-L1 expression of greater than or equal to (>=)50 percentage (%), per local testing, and are treatment-naïve in the metastatic setting
- Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiated
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Participant has an uncontrolled illness, including but not limited to: a. Uncontrolled diabetes, b. Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection), c. Active bleeding diathesis, d. Impaired oxygenation requiring continuous oxygen supplementation, e. Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
- Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
- Participant has a. (or has a history of) leptomeningeal disease (carcinomatous meningitis), b. spinal cord compression not definitively treated with surgery or radiation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
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Experimental: Phase 1 (Combination Dose Selection)
Participants will receive amivantamab low dose or high dose intravenous (IV) infusion based on body weight from Cycle 1 Day 1, Day 2, and subsequently Day 8, Day 15, and Day 22 and then every 2 weeks from Cycle 2 in combination with cetrelimab IV infusion from Cycle 1 Day 2 (after the Day 2 infusion of amivantamab). Cetrelimab treatment duration will be limited to a maximum of 24 months. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET). Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to a long term extension (LTE) phase. |
Amivantamab will be administered as IV infusion.
Outros nomes:
Cetrelimab will be administered as IV infusion.
Outros nomes:
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Experimental: Phase 2 (Dose Expansion)
Participants will receive amivantamab in combination with cetrelimab in Cohorts A and B at the RP2CD determined by the SET in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met. Cetrelimab treatment duration will be limited to a maximum of 24 months. Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to an LTE phase. |
Amivantamab will be administered as IV infusion.
Outros nomes:
Cetrelimab will be administered as IV infusion.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Phase 1: Number of Participants with Adverse events (AEs) by Severity
Prazo: Up to 2 years 3 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years 3 months
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Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Prazo: Up to Cycle 1 (Day 1 through Day 28)
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The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematological toxicity, pulmonary toxicity, liver enzyme elevation, treatment delay greater than (>) 28 days due to unresolved toxicity, or immune-related toxicity requiring the use of therapies in excess of corticosteroids. |
Up to Cycle 1 (Day 1 through Day 28)
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Phase 2: Objective Response Rate
Prazo: Up to 2 years 3 months
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ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as per investigator assessment. |
Up to 2 years 3 months
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Phase 1 and Phase 2: Number of Participants with AEs by Severity
Prazo: Up to 2 years 3 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years 3 months
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Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Prazo: Up to 2 years 3 months
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Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported. |
Up to 2 years 3 months
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Phase 2 : Duration of Response (DoR)
Prazo: Up to 2 years 3 months
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DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR. If a participant does not progress following a response, then his/her duration of response will be censored at the date of last evaluable disease assessment. Participants who started a subsequent anticancer therapy in the absence of progression will be censored at the last disease assessment before or on the start of subsequent therapy. |
Up to 2 years 3 months
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Phase 2: Disease Control Rate (DCR)
Prazo: Up to 2 years 3 months
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DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1 by investigator review. |
Up to 2 years 3 months
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Phase 2: Progression Free Survival (PFS)
Prazo: Up to 2 years 3 months
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PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at the time of their last evaluable RECIST v1.1 assessment. |
Up to 2 years 3 months
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Phase 2: Overall Survival (OS)
Prazo: Up to 2 years 3 months
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OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive. |
Up to 2 years 3 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- CR109323
- 61186372PANSC2002 (Outro identificador: Janssen Research & Development, LLC)
- 2022-501452-29-00 (Identificador de registro: EUCT number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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