Um estudo de agentes de investigação em participantes com câncer de pulmão não escamoso de células não pequenas (NSCLC) em estágio IV previamente tratado (MK-3475-01H/KEYMAKER-U01)
KEYMAKER-U01 Subestudo 01H: Um estudo guarda-chuva de fase 2, randomizado, com braços rotativos de agentes de investigação em participantes com câncer de pulmão não escamoso de células não pequenas (NSCLC) em estágio IV previamente tratado
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.
Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.
However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.
Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:
- About the safety of the study treatments and if people tolerate them
- How many people have the cancer respond to the study treatments
Visão geral do estudo
Status
Descrição detalhada
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Toll Free Number
- Número de telefone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Locais de estudo
-
-
-
Berlin, Alemanha, 13353
- Recrutamento
- Charite-Universitaetsmedizin Berlin ( Site 0191)
-
Contato:
- Study Coordinator
- Número de telefone: +49 30 450 553 044
-
-
Baden-Wurttemberg
-
Tübingen, Baden-Wurttemberg, Alemanha, 72076
- Recrutamento
- Universitaetsklinik Tuebingen ( Site 0192)
-
Contato:
- Study Coordinator
- Número de telefone: +4970712982795
-
-
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, Chile, 7500653
- Recrutamento
- Centro de Estudios Clínicos SAGA ( Site 0161)
-
Contato:
- Study Coordinator
- Número de telefone: +5690556961
-
Santiago, Region M. de Santiago, Chile, 8420383
- Recrutamento
- Bradfordhill ( Site 0162)
-
Contato:
- Study Coordinator
- Número de telefone: +56229490970
-
Santiago, Region M. de Santiago, Chile, 7500921
- Recrutamento
- Fundación Arturo López Pérez ( Site 0160)
-
Contato:
- Study Coordinator
- Número de telefone: 56227128000
-
-
-
-
-
Madrid, Espanha, 28223
- Recrutamento
- Hospital Universitario Quiron Madrid ( Site 0091)
-
Contato:
- Study Coordinator
- Número de telefone: 34914521987
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Espanha, 08908
- Recrutamento
- Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
-
Contato:
- Study Coordinator
- Número de telefone: 0034932607744
-
-
-
-
Kentucky
-
Lexington, Kentucky, Estados Unidos, 40536-0293
- Recrutamento
- University of Kentucky Chandler Medical Center ( Site 0019)
-
Contato:
- Study Coordinator
- Número de telefone: 859-257-1000
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21237
- Recrutamento
- MedStar Franklin Square Medical Center ( Site 0033)
-
Contato:
- Study Coordinator
- Número de telefone: 443-777-7147
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Recrutamento
- AHN Cancer Institute - Allegheny General ( Site 9501)
-
Contato:
- Study Coordinator
- Número de telefone: 412-325-5700
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75246-2046
- Recrutamento
- Texas Oncology - DFW ( Site 8003)
-
Contato:
- Study Coordinator
- Número de telefone: 214-370-1067
-
-
-
-
-
Thessaloniki, Grécia, 570 01
- Recrutamento
- European Interbalkan Medical Center ( Site 0205)
-
Contato:
- Study Coordinator
- Número de telefone: 0030 2310400213
-
-
Attica
-
Athens, Attica, Grécia, 115 27
- Recrutamento
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)
-
Contato:
- Study Coordinator
- Número de telefone: 0030 2107700220
-
-
-
-
Bács-Kiskun county
-
Kecskemét, Bács-Kiskun county, Hungria, 6000
- Recrutamento
- Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
-
Contato:
- Study Coordinator
- Número de telefone: +3676516700
-
-
Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Hungria, 9024
- Recrutamento
- Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
-
Contato:
- Study Coordinator
- Número de telefone: +3696507900
-
-
Jász-Nagykun-Szolnok
-
Szolnok, Jász-Nagykun-Szolnok, Hungria, 5000
- Recrutamento
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
-
Contato:
- Study Coordinator
- Número de telefone: +3656503603
-
-
Pest County
-
Törökbálint, Pest County, Hungria, 2045
- Recrutamento
- Református Pulmonológiai Centrum ( Site 0064)
-
Contato:
- Study Coordinator
- Número de telefone: +3623511570
-
-
-
-
-
Haifa, Israel, 3109601
- Recrutamento
- Rambam Health Care Campus ( Site 0076)
-
Contato:
- Study Coordinator
- Número de telefone: +972-4-7776234
-
Jerusalem, Israel, 9103102
- Recrutamento
- Shaare Zedek Medical Center ( Site 0075)
-
Contato:
- Study Coordinator
- Número de telefone: +972-2-6555768
-
Kfar Saba, Israel, 4428164
- Recrutamento
- Meir Medical Center ( Site 0071)
-
Contato:
- Study Coordinator
- Número de telefone: +97297472414
-
Petah Tikva, Israel, 4941492
- Recrutamento
- Rabin Medical Center ( Site 0074)
-
Contato:
- Study Coordinator
- Número de telefone: +97239378101
-
Ramat Gan, Israel, 5265601
- Recrutamento
- Sheba Medical Center ( Site 0070)
-
Contato:
- Study Coordinator
- Número de telefone: +97235307032
-
Tel Aviv, Israel, 6423906
- Recrutamento
- Sourasky Medical Center ( Site 0077)
-
Contato:
- Study Coordinator
- Número de telefone: +972-3-6973082
-
-
-
-
-
Florence, Itália, 50134
- Recrutamento
- Azienda Ospedaliera Universitaria Careggi ( Site 0173)
-
Contato:
- Study Coordinator
- Número de telefone: +393209225506
-
Milan, Itália, 20132
- Recrutamento
- Ospedale San Raffaele. ( Site 0171)
-
Contato:
- Study Coordinator
- Número de telefone: +390223903829
-
Roma, Itália, 00168
- Recrutamento
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
-
Contato:
- Study Coordinator
- Número de telefone: +390630156318
-
-
Lombardy
-
Milan, Lombardy, Itália, 20133
- Recrutamento
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
-
Contato:
- Study Coordinator
- Número de telefone: 390223902190
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polônia, 60-569
- Recrutamento
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
-
Contato:
- Study Coordinator
- Número de telefone: +48616654242
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polônia, 02-781
- Recrutamento
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
-
Contato:
- Study Coordinator
- Número de telefone: +48225463066
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polônia, 80-214
- Recrutamento
- Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
-
Contato:
- Study Coordinator
- Número de telefone: +48585844466
-
-
West Pomeranian Voivodeship
-
Koszalin, West Pomeranian Voivodeship, Polônia, 75-581
- Ativo, não recrutando
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
-
-
-
-
-
Adana, Turquia (Türkiye), 01250
- Recrutamento
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
-
Contato:
- Study Coordinator
- Número de telefone: +90 322 344 44 44
-
Ankara, Turquia (Türkiye), 06230
- Recrutamento
- Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
-
Contato:
- Study Coordinator
- Número de telefone: +90 312 305 43 36
-
Ankara, Turquia (Türkiye), 06800
- Recrutamento
- Ankara Bilkent Şehir Hastanesi. ( Site 0142)
-
Contato:
- Study Coordinator
- Número de telefone: +905555306271
-
Istanbul, Turquia (Türkiye), 34098
- Recrutamento
- I. U. Cerrahpasa Tip Fakultesi ( Site 0144)
-
Contato:
- Study Coordinator
- Número de telefone: +902124143000
-
Izmir, Turquia (Türkiye), 35100
- Recrutamento
- Ege Universitesi Hastanesi ( Site 0143)
-
Contato:
- Study Coordinator
- Número de telefone: +90 232 343 43 43
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC)
- Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy
- Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), c ros oncogene 1 negative (ROS1-), or other directed therapy is not indicated as primary therapy
- Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR
- Life expectancy of at least 3 months
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent
- Has adequate organ function
- If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
- Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
- Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
- Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Received radiation therapy to the lung
- Has uncontrolled or significant cardiovascular disorder prior to randomization
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
- Has clinically significant corneal disease
- Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
- Has inadequate washout period prior to randomization
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has previously received docetaxel as monotherapy or in combination with other therapies
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has evidence of any leptomeningeal disease
- Has history of interstitial lung disease (ILD)/pneumonitis, current diagnosis of ILD, and/or suspected ILD
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has history of allogeneic tissue/solid organ transplant
- Have not adequately recovered from major surgery or have ongoing surgical complications
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Raludotatug Deruxtecan
Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met. |
IV Infusion
Outros nomes:
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Outros nomes:
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Outros nomes:
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration |
|
Experimental: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met. |
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Outros nomes:
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Outros nomes:
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration IV Infusion
Outros nomes:
|
|
Comparador Ativo: Docetetaxel
Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met. |
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration IV Infusion |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response Rate (ORR)
Prazo: Up to approximately 81 months
|
ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. |
Up to approximately 81 months
|
|
Percentage of Participants with at Least One Adverse Event (AE)
Prazo: Up to approximately 81 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported. |
Up to approximately 81 months
|
|
Percentage of Participants Who Discontinued Medication Due to an AE
Prazo: Up to approximately 24 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported. |
Up to approximately 24 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of Response (DOR)
Prazo: Up to approximately 81 months
|
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to approximately 81 months
|
|
Progression-free Survival (PFS)
Prazo: Up to approximately 81 months
|
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. |
Up to approximately 81 months
|
|
Overall Survival (OS)
Prazo: Up to approximately 81 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 81 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
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
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Carcinoma pulmonar de células não pequenas
- Doença de Parkinson 4, Corpo Autossômico Dominante de Lewy
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Hormônios
- Hormônios, substitutos hormonais e antagonistas hormonais
- Agentes Neurotransmissores
- Antagonistas da serotonina
- Agentes serotonina
- Ações farmacológicas
- Ações e usos químicos
- Antagonistas do receptor de serotonina 5-HT3
- Antagonistas do receptor de neurocinina-1
- Hormônios do córtex adrenal
Outros números de identificação do estudo
- 3475-01H
- KEYMAKER-U01 (Outro identificador: MSD)
- MK-3475-01H (Outro identificador: MSD)
- U1111-1314-1785 (Identificador de registro: UTN)
- 2024-518761-10-00 (Identificador de registro: EU CT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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 .