Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer

Launched by SOROKA UNIVERSITY MEDICAL CENTER · Aug 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether a treatment called Fecal Microbiota Transplant (FMT) can improve the effectiveness of immunotherapy for patients with metastatic lung cancer. Immunotherapy is a type of treatment that helps the immune system fight cancer, but not all patients respond well to it. The researchers believe that by altering the gut microbiome—a collection of bacteria in the digestive system—through FMT, they might enhance how patients respond to immunotherapy. The main goal of the study is to assess how safe and effective this combination treatment might be in helping patients control their disease better.

To participate in this trial, patients need to be adults over 18 years old with a confirmed diagnosis of lung cancer and be planning to receive standard cancer treatments like chemotherapy or immune checkpoint inhibitors. They must also be in reasonably good health overall. Participants will undergo specific procedures and evaluations to monitor their health and see how their gut microbiome changes during the treatment. It's important to know that certain conditions or recent treatments may exclude some patients from participating, so discussing eligibility with a healthcare provider is crucial.

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ALL

Eligibility criteria

• Patient (Recipient) Inclusion Criteria:
• • 1. A histologically confirmed diagnosis of malignancy.
• • 2. Patients over the age of 18.
• • 3. Patients planning to be treated with chemotherapy, immune checkpoint inhibitors and/or targeted therapy.
• • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• • 5. Able to provide written informed consent.
• Patient (Recipient) Exclusion Criteria:
• • 1. Severe or life-threatening food allergy (e.g. nuts, seafood)
• • 2. Allergy or other contraindication to omeprazole, investigational medicinal product.
• • 3. Treatment with pre- or probiotics in the four weeks prior to randomization.
• 4. Severe immunodeficiency:
• • Systemic chemotherapy \<30 days from baseline
• • Known neutropenia with absolute neutrophils \<1.0x109 cells/µL
• • Prolonged treatment with corticosteroids (equivalent to prednisone \>60mg daily for \>30 days) within 8 weeks of randomization
• • 5. Swallowing disorder, oral-motor discoordination, inability to swallow capsules
• • 6. Pregnant or breastfeeding or expecting to conceive or father children within the trial's projected duration, starting from the pre-screening or screening visit through to 120 days after the last dose of trial treatment.
• Donor Inclusion Criteria:
• • 1. A histologically confirmed diagnosis of malignancy.
• • 2. Over the age of 18.
• • 3. Treated with immune checkpoint inhibitors and with a full response.
• • 4. Currently attending medical follow-ups
• Donor Exclusion Criteria:
• • 1. Has not consumed any antimicrobials within the past 3 months
• • 2. No prior exposure to HIV or viral hepatitis or suffering from tuberculosis/latent tuberculosis
• • 3. No risk factors for blood-borne viruses, including high-risk sexual behavior, use of illicit drugs, any tattoo/body piercing/needlestick injury/blood transfusion/acupuncture, all within the past 6 months
• • 4. No signs or symptoms consistent with Coronavirus disease 19 (COVID-19) or a nose/throat and/or stool sample with detectable Coronavirus disease 2 (CoV-2)
• • 5. Has not received a live attenuated vaccine within the past 6 months
• • 6. No underlying gastrointestinal conditions/symptoms (e.g., history of IBD, irritable bowel syndrome (IBS), chronic diarrhea, chronic constipation, coeliac disease, bowel resection or bariatric surgery)
• • 7. No acute diarrhea/gastrointestinal symptoms within the 2 weeks prior to donating
• • 8. No family history of any significant gastrointestinal conditions (e.g., family history of inflammatory bowel disease (IBD) or colorectal cancer)
• • 9. No history of atopy (e.g., asthma, eosinophilic disorders)
• • 10. Does not suffer from any systemic autoimmune conditions
• • 11. Does not start any new treatment regimens within 2 weeks of fecal collection
• • 12. No neurological or psychiatric conditions or known risk for prion disease
• • 13. No history of chronic pain syndromes, including chronic fatigue syndrome and fibromyalgia
• • 14. No history of receiving growth hormone, insulin from cows or clotting factor concentrates
• • 15. Has not received an experimental drug or vaccine within the past 6 months
• • 16. No history of travel to tropical countries within the past 6 months