Fecal microbiota transplant combined with immune therapy for lung cancer

Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Metastatic Lung Cancer

This study is testing whether a fecal transplant from healthy donors can help improve the effectiveness of immune therapy in people with advanced lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Soroka University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Immunotherapy
• Locations: 2 sites (Beersheba and 1 other locations)
• Trial ID: NCT05502913 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with metastatic lung cancer receiving first-line (chemo-)immunotherapy. The approach involves using fecal samples from patients who have responded well to immunotherapy as donors for the transplant. Participants will receive FMT alongside their treatment regimen, with regular assessments of their microbiome composition and clinical outcomes. The study aims to enhance the effectiveness of immunotherapy by modulating the gut microbiome.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of metastatic lung cancer who are planning to undergo chemotherapy or immunotherapy.

Not a fit: Patients with severe immunodeficiency or those who have contraindications to the treatment components may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with metastatic lung cancer receiving immunotherapy.

How similar studies have performed: While the use of fecal microbiota transplantation in cancer treatment is emerging, this specific combination with immune checkpoint inhibitors is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Beersheba and 1 other locations

• Soroka Medical Center — Beersheba, Israel (Recruiting)
• Rabin Medical Center — Petah Tikva, Israel (Not_yet_recruiting)

Study contacts

• Principal investigator: Ismaell Massalha, MD — Soroka University Medical Center
• Study coordinator: Ismaell Massalha, M.D.

Conditions Metastatic Lung Cancer; Fecal microbiome transplant; Metastatic lung cancer