Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer
ConditionMetastatic Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoroka University Medical Center
About this trial
Immunotherapy has recently become a main-stream treatment option in cancer care, with improved clinical outcomes in many malignancies, especially that of lung cancer. The long-term benefits of this treatment however are limited. There is therefore a critical need to distinguish predictive biomarkers of response from those of resistance, and to develop synergistic strategies for improved therapeutic response. Strong emerging evidence indicates that the gut microbiome has the ability to influence response to immunotherapy. Unlike tumor genomics, the gut microbiome is modifiable, and thus its modulation to enhance response to immunotherapy is an attractive therapeutic strategy.
Working hypothesis: Fecal Microbiota Transplant (FMT) treatment in conjunction with standard (chemo-)immunotherapy as a first-line treatment for metastatic lung cancer enhances disease control rate.
The main objective of this study is to evaluate the safety and efficacy of Fecal Microbiota Transplant (FMT) in altering response to immunotherapy in patients with metastatic lung cancer. The overall goal is to determine microbiome compositional and gene-content changes in patients who respond more efficiently to immunotherapy subsequent to FMT. This understanding may lead to future microbiome-based treatments in combination with immunotherapy to significantly increase lung cancer treatment efficacy. In this prospective clinical and molecular study, we will perform an in-depth analysis of the potential role of FMT in the context of immunotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A histologically confirmed diagnosis of malignancy.
Patients over the age of 18.
Patients planning to be treated with chemotherapy, immune checkpoint inhibitors and/or targeted therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Disqualifiers
Severe or life-threatening food allergy (e.g. nuts, seafood)
Allergy or other contraindication to omeprazole, investigational medicinal product.
Treatment with pre- or probiotics in the four weeks prior to randomization.
Systemic chemotherapy <30 days from baseline
Trial design
Design model
Parallel
Treatments tested in this trial
Antibiotics
DrugRecipients will undergo bowel preconditioning with antibiotics (Rifaximin) following randomization.
FMT (Fecal Microbiota Transplantation)
Other interventionFMT involves the transplantation of fecal bacteria from a screened donor to a recipient. This will be achieved per os in the form of a capsule containing freeze-dried stool obtained from the donor.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: standard of care (SoC) (IO±CTX) + FMTExperimental treatment 2 interventions
Group B: standard-of-care treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Progression-free Survival (PFS)
PFS is defined as the time passed from screening until the date of progressive disease (PD) or death from any cause. Imaging will be performed using computed tomography (CT) and/or Positron emission tomography (PET).
Time frame
up to 2 yearsSecondary outcomes
1
Overall Survival (OS)
OS is defined as the time passed from randomization until death from any cause.
Time frame
up to 4 years2
Objective response rate (ORR)
ORR is defined as the percentage of subjects who had a complete response (CR) or partial response (PR), as defined by ir-RECIST v1.1, and is based on the best response obtained.
Time frame
From randomization (Day 0) until end of study3
Rate of Disease Control
Rate of Disease Control is defined as the percentage of subjects who had a complete response (CR), partial response (PR), or stable disease (SD), as defined by ir-RECIST v1.1.
Time frame
up to 2 years4
Microbiome analysis
Microbiome analysis of the stool of donors and recipients (before and after FMT) to reveal the optimum microbiome-based components to significantly increase cancer immunotherapy efficacy
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Soroka University Medical Center
Lead sponsor
Biotax Labs LTD
Collaborator
Israel Cancer Association
Collaborator
Source ClinicalTrials.gov