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Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic NSCLC

ConditionNon Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSe-Hoon Lee

About this trial

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 clinical need. This study aims to provide evidence to address this issue. Fecal microbiota transplantation (FMT) is a means that can rapidly and efficiently change the intestinal microbiota and has the potential to affect the systemic immune environment. Therefore, this study intends to contribute to the development of future treatment strategies by evaluating whether FMT can restore the immune response and clinical efficacy in patients with immune checkpoint inhibitor-resistant NSCLC.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

DONOR

Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab 200mg IV q3wks

  • Fecal Microbiota Transplant(FMT)

    Procedure/Surgery

    FMT through colonoscopy q9wks up to 3 cycles.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Fecal Microbiota Transplant(FMT) combination with TislelizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety(SAE, AE)

to evaluate the clinical safety (by NCI-CTCAE v5.0)

Time frame
From enrollment to the EOT, up to 42 months

Secondary outcomes

1

ORR

To evaluate of clinical efficacy (by RECIST v1.1)

Time frame
up to 42 months
2

OS

To evaluate of clinical efficacy (by Kaplan-Meier method)

Time frame
up to 42 months
3

PFS

To evaluate of clinical efficacy (by Kaplan-Meier method)

Time frame
up to 42 months
4

DCR

To evaluate of clinical efficacy (by RECIST v1.1)

Time frame
up to 42 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Se-Hoon Lee

Lead sponsor

Samsung Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: