Trilaciclibe vs Placebo em Pacientes com Câncer de Pulmão de Pequenas Células em Estágio Extensivo (ES-SCLC) Recebendo Topotecano
Um estudo randomizado, duplo-cego, controlado por placebo de trilaciclibe versus placebo em pacientes com câncer de pulmão de pequenas células em estágio extenso (ES-SCLC) recebendo quimioterapia com topotecano
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
-
Seville, Espanha
- Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
- Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
- Measurable or evaluable disease as defined by RECIST v1.1
Exclusion Criteria:
- History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
- Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
- Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
- Radiotherapy within 2 weeks
- History of ILD/pneumonitis
- History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²) |
Participants will receive intravenous trilaciclib infusion
Outros nomes:
Participants will receive intravenous topotecan infusion
Outros nomes:
|
|
Comparador de Placebo: Placebo + Topotecan 1.5 mg/m²
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²). |
Participants will receive intravenous topotecan infusion
Outros nomes:
Participants will receive intravenous placebo infusion |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall survival (OS)
Prazo: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
|
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan |
From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anti-tumor efficacy
Prazo: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
|
To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan |
From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
|
|
Anti-tumor efficacy
Prazo: From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
|
To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan |
From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
|
|
Anti-tumor efficacy
Prazo: From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
|
To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan |
From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
|
|
Neutrophil-related myeloprotection efficacy
Prazo: From date of randomization until end of cycle 1 (each cycle is 21 days)
|
Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1 |
From date of randomization until end of cycle 1 (each cycle is 21 days)
|
|
Neutrophil-related myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Neutrophil-related myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of G-CSF administration |
From date of randomization until end of treatment, assessed up to 52 months
|
|
RBC related myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration |
From date of randomization until end of treatment, assessed up to 52 months
|
|
RBC related myeloprotection efficacy
Prazo: From date of randomization until end of Week 5
|
RBC transfusions on or after Week 5 (occurrence) |
From date of randomization until end of Week 5
|
|
RBC related myeloprotection efficacy
Prazo: From date of randomization until end of Week 5
|
RBC transfusions on or after Week 5 (number of transfusions) |
From date of randomization until end of Week 5
|
|
Platelet related myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence) |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Platelet related myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions) |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Myeloprotection efficacy
Prazo: From date of randomization until end of treatment, assessed up to 52 months
|
Number of hospitalizations due to chemotherapy-induced myelosuppression |
From date of randomization until end of treatment, assessed up to 52 months
|
|
Chemotherapy dosing
Prazo: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan. |
From the date of randomization until end of treatment, assessed up to 52 months
|
|
Chemotherapy dosing
Prazo: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan. |
From the date of randomization until end of treatment, assessed up to 52 months
|
|
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
Prazo: From the date of randomization until end of treatment, assessed up to 52 months
|
To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest |
From the date of randomization until end of treatment, assessed up to 52 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Pharmacosmos Clinical and non-clinical Department, Pharmacosmos A/S
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 pequenas células
- Compostos heterocíclicos
- Camptothecin
- Alcalóides
- Topotecano
- Trilaciclib
Outros números de identificação do estudo
- G1T28-211
- 2022-502357-34-00 (Outro identificador: EU-CTR)
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 .