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O estudo clínico NCT07432984 (FMT-LUNG) para Câncer de pulmão de células não pequenas está ainda não recrutando. 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.
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Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic NSCLC (FMT-LUNG) Fase II 15 Imunoterapia Microbioma Personalizado

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O estudo clínico NCT07432984 (FMT-LUNG) vai avaliar tratamento para Câncer de pulmão de células não pequenas. Este é um estudo intervencionista de Fase II. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 30 de abril de 2026, com o objetivo de incluir 15 participantes. Coordenado por Se-Hoon Lee e deve ser concluído em 30 de outubro de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de fevereiro de 2026.
Resumo
This study aims to investigate the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for non-small cell lung cancer (NSCLC) patients whose disease has progressed after immune checkpoint inhibitor (ICI) therapy, and to establish the foundation for personalized FMT through gut microbiome analysis.

Recovering immune responses in patients who have failed prior immunotherapy remains an unmet cl...

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Descrição detalhada
The most significant improvement in response rates has been demonstrated by whole microbiome intervention via fecal microbiota transplantation (FMT) has demonstrated the most significant improvement in response rates compared to individual species-based interventions.

In light of the established clinical efficacy of ICIs and FMT in patients with solid malignancies, a phase II study was designed to investigate the po...

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Título oficial

Efficacy and Safety of Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed After Prior Immune Checkpoint Inhibitors

Condições médicas
Câncer de pulmão de células não pequenas
Outros IDs do estudo
  • FMT-LUNG
  • 2025-12-108
Número NCT
NCT07432984
Data de início (real)
2026-04-30
Última atualização postada
2026-02-25
Data de conclusão (estimada)
2029-10-30
Inscrição (estimada)
15
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalFecal Microbiota Transplant(FMT) combination with Tislelizumab
A fixed dose of 200mg Q3W Tislelizumab IV until PD And Q9W FMT (max 3)
Tislelizumab
Tislelizumab 200mg IV q3wks
Fecal Microbiota Transplant(FMT)
FMT through colonoscopy q9wks up to 3 cycles.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Safety(SAE, AE)
to evaluate the clinical safety (by NCI-CTCAE v5.0)
From enrollment to the EOT, up to 42 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
ORR
To evaluate of clinical efficacy (by RECIST v1.1)
up to 42 months
OS
To evaluate of clinical efficacy (by Kaplan-Meier method)
up to 42 months
PFS
To evaluate of clinical efficacy (by Kaplan-Meier method)
up to 42 months
DCR
To evaluate of clinical efficacy (by RECIST v1.1)
up to 42 months
DOR
To evaluate of clinical efficacy (by RECIST v1.1)
up to 42 months
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
19 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim

  • DONOR

    ① Subjects who have voluntarily provided written Informed consent to participate in this clinical trial

    ② Aged of 19 or older

    ③ Subjects who meet one of the following criteria:

    1. Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy
    2. Healthy volunteers with no history of inflammatory bowel disease ④ Subjects who agree to provide repetitive blood and fecal samples during the trial period

  • RECIPIENT

    • Have voluntarily provided written Informed consent to participate in this clinical trial

      • Adults aged 19 years or older

        • Histologically or cytologically confirmed progressive or metastatic NSCLC

          • Subjects with at least one measurable lesion according to RECIST v1.1

            • Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.)

              • ECOG 0-1

                • Subjects with a life expectancy is at least 3 months ⑧ Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:

                  1. Absolute neutrophil count (ANC): ≥ 1.5×109/L

                  2. Hemoglobin: ≥ 9.0 g/dL

                  3. Platelet count: ≥ 75×109/L

                  4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault

                  5. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)

                  6. Total bilirubin: ≤ 1.5×ULN (< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases) ⑨ Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug ⑩ Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation

                    ⑪ Agreed to provide blood and fecal samples during the trial period

  • DONOR

    • Have voluntarily provided written Informed consent to participate in this clinical trial

      • Adults aged 19 years or older

        • Histologically or cytologically confirmed progressive or metastatic NSCLC

          • Subjects with at least one measurable lesion according to RECIST v1.1

            • Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.) ⑥ ECOG 0-1

              • Subjects with a life expectancy is at least 3 months

                • Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:

                  1. Absolute neutrophil count (ANC): ≥ 1.5×109/L

                  2. Hemoglobin: ≥ 9.0 g/dL

                  3. Platelet count: ≥ 75×109/L

                  4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault

                  5. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)

                  6. Total bilirubin: ≤ 1.5×ULN (< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases)

                    • Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug

                      • Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation

                        • Agreed to provide blood and fecal samples during the trial period

  • RECIPIENT

    • Have voluntarily provided written Informed consent to participate in this clinical trial

      • Adults aged 19 years or older

        • Histologically or cytologically confirmed progressive or metastatic NSCLC

          • Subjects with at least one measurable lesion according to RECIST v1.1

            • Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.)

              • ECOG 0-1 ⑦ Subjects with a life expectancy is at least 3 months

                • Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:

                  1. Absolute neutrophil count (ANC): ≥ 1.5×109/L

                  2. Hemoglobin: ≥ 9.0 g/dL

                  3. Platelet count: ≥ 75×109/L

                  4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault

                  5. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)

                  6. Total bilirubin: ≤ 1.5×ULN (< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases)

                    • Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug ⑩ Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation

                      • Agreed to provide blood and fecal samples during the trial period
Se-Hoon Lee logoSe-Hoon Lee
Responsável pelo estudo
Se-Hoon Lee, Patrocinador-Investigador, Principal Investigator, Samsung Medical Center
Contato central do estudo
Contato: Sehoon Lee, Ph.MD, +82-2-3410-3459, [email protected]
Sem dados de locais.