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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Able to provide written informed consent.

• A histologically confirmed diagnosis of malignancy.

• Over the age of 18.

• Treated with immune checkpoint inhibitors and with a full response.

• Currently attending medical follow-ups

Locations
Other Locations
Israel
Soroka Medical Center
RECRUITING
Beersheba
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Contact Information
Primary
Ismaell Massalha, M.D.
ismaell@post.bgu.ac.il
+972526995934
Backup
Amichay Meirovitz, Prof.
amichaym@gmail.com
+972528805922
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 80
Treatments
Experimental: standard of care (SoC) (IO±CTX) + FMT
Subjects assigned to Arm 1 will be required to swallow FMT capsules in a regimen of ten capsules in the morning and ten capsules in the afternoon on day 1 of the first (chemo-)immunotherapy cycle, and then every three weeks.~abbreviation: Immuno-Oncology (IO) Chemotherapy (CTX)
No_intervention: standard-of-care treatment
Subjects will receive standard-of-care treatment only.
Related Therapeutic Areas
Sponsors
Leads: Soroka University Medical Center
Collaborators: Biotax Labs LTD, Israel Cancer Association

This content was sourced from clinicaltrials.gov