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New treatment option for Metastatic Lung Cancer
Official title Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer
ClinicalTrials.gov ID: NCT05502913
What this study is testing
What is Antibiotics?
Antibiotics is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic lung cancer.
Also referred to as Rifaximin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient (Recipient)
- 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
You likely can't join if
- 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.
- Severe immunodeficiency:
- Systemic chemotherapy \<30 days from baseline
- Known neutropenia with absolute neutrophils \<1.0x109 cells/µL
See the full eligibility criteria
- Patient (Recipient)
- 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. Patient (Recipient)
- 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.
- 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
- Swallowing disorder, oral-motor discoordination, inability to swallow capsules
- 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...
- 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 Donor Exclusion Criteria:
- Has not consumed any antimicrobials within the past 3 months
- No prior exposure to HIV or viral hepatitis or suffering from tuberculosis/latent tuberculosis
- 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
- 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)
- Has not received a live attenuated vaccine within the past 6 months
- 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)
- No acute diarrhea/gastrointestinal symptoms within the 2 weeks prior to donating
- No family history of any significant gastrointestinal conditions (e.g., family history of inflammatory bowel disease (IBD) or colorectal cancer)
- No history of atopy (e.g., asthma, eosinophilic disorders)
- Does not suffer from any systemic autoimmune conditions
- Does not start any new treatment regimens within 2 weeks of fecal collection
- No neurological or psychiatric conditions or known risk for prion disease
- No history of chronic pain syndromes, including chronic fatigue syndrome and fibromyalgia
- No history of receiving growth hormone, insulin from cows or clotting factor concentrates
- Has not received an experimental drug or vaccine within the past 6 months
- No history of travel to tropical countries within the past 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Beersheba, Israel
- Petah Tikva, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beersheba, Israel; Petah Tikva, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.