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Microbiota Therapy
FMT + Pembrolizumab for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Diwakar Davar, MD
Research Sponsored by Diwakar Davar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have progressed on treatment with an anti-PD(L)1 ICI administered either as monotherapy or in combination with other checkpoint inhibitors or other standard/investigational therapies.
Histologically or cytologically confirmed diagnosis of stage IV PD-L1+ NSCLC. Patients with either squamous or non-squamous NSCLC may enroll. Documented PD-L1 status (defined as 1% or greater) as determined by immunohistochemistry with anti-PD-L1 antibody (IHC 22C3 pharmDx or other FDA approved diagnostic method) from a core or excisional biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests if a fecal transplant can help people with cancer fight back better.
Who is the study for?
Adults with PD-L1 Positive NSCLC that has worsened after anti-PD(L)1 therapy can join. They must have measurable disease, good organ function, and agree to use contraception. Excluded are those pregnant or breastfeeding, with certain infections like active COVID-19 or HIV, severe allergies to immunotherapy drugs, recent live vaccines, autoimmune diseases needing treatment in the last 2 years, or other cancers within 3 years.Check my eligibility
What is being tested?
The trial is testing if fecal microbiota transplant (FMT) can boost the immune system's cancer-fighting abilities when combined with Pembrolizumab in patients whose NSCLC has relapsed or is resistant to previous treatments. Participants will receive FMT through endoscopic procedures alongside standard immunotherapy.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related symptoms from Pembrolizumab such as fever and chills, digestive issues due to FMT including bloating and diarrhea, fatigue from both treatments and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment with specific immune therapy.
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My stage IV lung cancer tests positive for PD-L1.
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I can provide a fresh biopsy of my tumor that hasn't been treated with radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) per RECIST v1.1
Secondary outcome measures
1-year Overall Survival (OS)
1-year Progression-free Survival (PFS)
2-year Overall Survival (OS)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota Transplant (FMT) with PembrolizumabExperimental Treatment2 Interventions
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy (Treatment Phase 1) and by a sigmoidoscopy (Treatment Phase 2). FMT will be performed on Cycle 1 Day 1 and Cycle 3 Day 1 during Treatment Phase 1 and every 9 weeks starting with Cycle 4 Day 1 during Treatment Phase 2.
Pembrolizumab, 200mg, will be administered as a 30-minute IV infusion every 3 weeks starting Cycle 1 Day 1 (same day as the FMT), and continue on Day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant (FMT)
2015
Completed Phase 2
~80
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,544 Total Patients Enrolled
Diwakar DavarLead Sponsor
10 Previous Clinical Trials
385 Total Patients Enrolled
Gateway Fund for Cancer Research (GFCR)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the contraception guidelines and not donate sperm for 120 days after my last treatment.My cancer has worsened despite treatment with specific immune therapy.You are expected to live for at least 12 weeks, based on a specific scoring system.I have not received a live vaccine in the last 30 days.I do not have active infections like TB, COVID-19, HIV, or Hepatitis B/C.I cannot receive FMT due to specific health reasons.I am not pregnant or breastfeeding and will follow birth control guidelines for 120 days after treatment.I am taking more than 10 mg of prednisone daily for a systemic condition.I have or had lung inflammation that needed steroids.My stage IV lung cancer tests positive for PD-L1.You have a disease that can be measured using specific guidelines.I am 18 years or older and have given my consent to participate.I have received an organ or tissue transplant from another person.My lung cancer is not squamous but may be small cell, large cell, neuroendocrine, or sarcomatoid.I have taken treatments targeting my gut bacteria.I have an immune system disorder or am on long-term steroids.I am willing to undergo repeated FMT treatments via endoscopy after preparing my bowels.My organs are functioning well.My cancer has spread to my brain and is causing symptoms or growing.You have a very bad allergic reaction (Grade 3 or higher) to anti-PD(L)1 inhibitor.I can provide a fresh biopsy of my tumor that hasn't been treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.I have a heart condition that needs ongoing treatment.I have an autoimmune disease treated with medication in the last 2 years.I haven't had any other cancer besides blood cancer in the last 3 years.My brain metastases are stable and treated before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplant (FMT) with Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any adverse effects associated with the combination of Fecal Microbiota Transplant and Pembrolizumab?
"The associated risk of Fecal Microbiota Transplant (FMT) with Pembrolizumab is estimated to be a 2, due to the Phase 2 trial status. While there are some safety data available, efficacy has yet to be demonstrated."
Answered by AI
Are there any new openings for volunteers in this clinical experiment?
"Information hosted on clinicaltrials.gov states that this study has ceased its recruitment of patients, the last alteration to the trial having been made in December 2022. While no longer enrolling candidates, there are currently 1471 other trials seeking participants."
Answered by AI
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