Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy
20 de abril de 2021 atualizado por: Eli Lilly and Company
Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of participants with advanced stage non-small cell lung cancer.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Fase 2
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
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Arkansas
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Bentonville, Arkansas, Estados Unidos, 72712
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Galesburg, Illinois, Estados Unidos, 61401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Bloomington, Indiana, Estados Unidos, 47403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Evansville, Indiana, Estados Unidos, 47714
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fort Wayne, Indiana, Estados Unidos, 46815
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indianapolis, Indiana, Estados Unidos, 46202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lafayette, Indiana, Estados Unidos, 47904
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Muncie, Indiana, Estados Unidos, 47303
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Bend, Indiana, Estados Unidos, 46601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Jackson, Michigan, Estados Unidos, 49201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- participants or their legal representative must have signed an informed consent document for clinical research
- have laboratory confirmed diagnosis of advanced, nonsquamous cell non-small cell lung cancer (NSCLC) (Stage IIIB or IV disease) which is not curable
- have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
- have measurable disease
- have adequate organ function and estimated life expectancy of 12 weeks
Exclusion Criteria:
- have known central nervous system (CNS) disease; major surgery within 28 days; minor surgery within 7 days; serious concomitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
- have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
- have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
- are pregnant or breast-feeding
- are unable to swallow tablets
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: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: A
Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
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1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression
Outros nomes:
500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles
Outros nomes:
Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
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Comparador de Placebo: B
Pemetrexed + Carboplatin + Bevacizumab + Placebo
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500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles
Outros nomes:
Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
oral, daily
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Progression-Free Survival (PFS)
Prazo: Randomization to measured PD or death from any cause up to 12.2 months
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PFS was defined as the time from date of randomization to the first observation of progressive disease (PD) or death due to any cause.
For participants not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of the last objective progression-free assessment.
For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to objective disease progression or death, PFS was censored at the date of the last objective progression-free assessment prior to the initiation of post-discontinuation anticancer therapy.
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Randomization to measured PD or death from any cause up to 12.2 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)
Prazo: Randomization to measured progressive disease or death from any cause up to 12.2 months
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Tumor response rate was defined as number of participants with overall best response of CR or PR over number of protocol qualified participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case, no new lesions may have appeared. Percentage of participants was calculated as: (number of participants with CR or PR/ number of participants qualified for tumor response analysis) × 100. |
Randomization to measured progressive disease or death from any cause up to 12.2 months
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Overall Survival (OS)
Prazo: Randomization to date of death up to 14.3 months
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OS was defined as the time from the date of randomization to the date of death from any cause.
For participants who were not known to have died as of the data cutoff, OS was censored at the last contact date.
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Randomization to date of death up to 14.3 months
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Time to Progressive Disease (TTPD)
Prazo: Randomization to measured PD or death from any cause up to 12.2 months
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TTPD was defined as the time from the date of randomization until the first date of objectively determined progressive disease (PD).
For participants who died without objective PD (including death from study disease), TTPD was censored at the date of the last objective progression-free disease assessment.
For participants not known to have died as of the data cutoff and did not have PD, TTPD was censored at the date of the last objective progression-free disease assessment.
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Randomization to measured PD or death from any cause up to 12.2 months
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Duration of Response (DoR)
Prazo: Time of response to disease progression or death from any cause up to 12.2 months
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The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death from any cause.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria.
CR was defined as the disappearance of all target lesions and PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs.
For participants who died without progressive disease or who were alive, DoR was censored at the last contact of progression free assessment.
For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to PD, DoR was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation anticancer therapy.
Due to early study closure, DoR was not analyzed.
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Time of response to disease progression or death from any cause up to 12.2 months
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Pharmacology Toxicity and Adverse Events (AEs)
Prazo: Randomization up to 14.3 months and 30-day follow-up
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Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs.
Participants who died due to progressive disease (PD) or an AE while on treatment and or died during the 30 day post-treatment follow-up are included.
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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Randomization up to 14.3 months and 30-day follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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
1 de outubro de 2007
Conclusão Primária (Real)
1 de fevereiro de 2009
Conclusão do estudo (Real)
1 de fevereiro de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
19 de setembro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de setembro de 2007
Primeira postagem (Estimativa)
21 de setembro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Antagonistas do ácido fólico
- Carboplatina
- Bevacizumabe
- Pemetrexede
Outros números de identificação do estudo
- 11398
- H6Q-MC-S034 (Outro identificador: Eli Lilly and Company)
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 .
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