beta
IA Trial Radar
O estudo clínico NCT06953843 para CPNPC estágio IV sem mutação EGFR/ALK está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa

Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases Fase II 366 Imunoterapia

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06953843 procura avaliar tratamento para CPNPC estágio IV sem mutação EGFR/ALK. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 9 de julho de 2025 e pretende incluir 366 participantes. Coordenado por Xinqiao Hospital of Chongqing e deve ser concluído em 31 de dezembro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 14 de julho de 2025.
Resumo
This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with...Mostrar mais
Título oficial

An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer

Condições médicas
CPNPC estágio IV sem mutação EGFR/ALK
Outros IDs do estudo
  • XQonc-023
Número NCT
NCT06953843
Data de início (real)
2025-07-09
Última atualização postada
2025-07-14
Data de conclusão (estimada)
2027-12-31
Inscrição (estimada)
366
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Propósito principal
Tratamento
Alocação do design
Não randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalGroup A
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
ExperimentalGroup B
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.
ExperimentalGroup C
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
ExperimentalGroup D
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.
ExperimentalGroup E
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
ExperimentalGroup F
Benmelstobart combined with Bevacizumab and chemotherapy
For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
The remission rate of abscopal lesions
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
PFS
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
OS
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival
up to 5 years
AE
The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos

  • Patient must meet all of the following inclusion criteria to be enrolled in this study:

    1. Non-small cell lung cancer confirmed by pathological histology.
    2. More than 3 metastatic lesions.
    3. No brain metastases or stable lesions.
    4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
    5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
    6. Age between 18 and 75 years old.
    7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
    8. No contraindications to immunotherapy and radiotherapy.
    9. Signed the informed consent form.

  • Patients with any of the following criteria are not eligible for enrollment in this study:

    1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
    2. Those accompanied by other malignant tumors.
    3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
    4. Those with a history of mental illness.
    5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
Xinqiao Hospital of Chongqing logoXinqiao Hospital of Chongqing
Responsável pelo estudo
Jianguo Sun, Investigador principal, Prof, Xinqiao Hospital of Chongqing
Contato central do estudo
Contato: Jianguo Sun, MD, 86-13983155736, [email protected]
1 Locais do estudo em 1 países

Chongqing Municipality

the second affiliated hospital of Army medical university, Chongqing, Chongqing Municipality, 400037, China
jianguo Sun, Phd, Contato, 023-68774490, [email protected]
Em recrutamento