Actively Recruiting
Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC
Led by Diwakar Davar · Updated on 2026-03-23
26
Participants Needed
1
Research Sites
625 weeks
Total Duration
On this page
Sponsors
D
Diwakar Davar
Lead Sponsor
G
Gateway for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to determine if Healthy Donor FMT (hdFMT) improves the body's ability to fight cancer in patients with relapsed/refractory PD-L1 Positive NSCLC.
CONDITIONS
Official Title
Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants must agree to use contraception during treatment and for 120 days after the last dose and not donate sperm during this time.
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and for 120 days after the last dose.
- Histologically or cytologically confirmed stage IV PD-L1+ NSCLC, including squamous or non-squamous types.
- Documented PD-L1 status of 1% or greater by approved immunohistochemistry.
- Participants must have progressed on anti-PD(L)1 immune checkpoint inhibitor therapy with documented disease progression confirmed by RECIST v1.1.
- Patients with treated and stable central nervous system metastases may enroll.
- Prior anti-CTLA-4 therapy allowed.
- Patients with oncogenic driver mutations must have received and progressed after targeted therapy.
- Willingness to receive FMT via endoscopic procedures and pills.
- Presence of measurable disease with at least one lesion plus a separate lesion for biopsy.
- ECOG performance status of 0 or 1.
- Adequate organ function.
- For hepatitis B or C positive patients, must have completed antiviral therapy with undetectable viral load prior to enrollment.
You will not qualify if you...
- NSCLC histologies other than squamous or adenocarcinoma, including small cell, large cell, neuroendocrine, or sarcomatoid.
- Prior therapies targeting the intestinal microbiome (e.g., FMT or defined bacterial therapies).
- Chemotherapy, targeted therapy, or small molecule therapy within 2 weeks before study start.
- Radiotherapy within 2 weeks prior to study start without recovery.
- Toxic megacolon, severe dietary allergies, or inflammatory bowel disease.
- Unresolved adverse events from prior treatments.
- Positive pregnancy test.
- Receipt of live vaccines within 30 days before study drug.
- Immunodeficiency or immunosuppressive therapy exceeding prednisone 10 mg daily within 14 days before study drug.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- Concurrent non-hematologic malignancy within 3 years except certain low-risk cancers.
- Active or growing central nervous system metastases or leptomeningeal disease.
- Severe hypersensitivity to anti-PD(L)1 inhibitors.
- Systemic disease requiring high-dose corticosteroids.
- History of interstitial lung disease, active pneumonitis, or non-infectious myocarditis.
- Active infections including TB, HIV, active hepatitis B or C, or COVID-19.
- Psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnancy, breastfeeding, or planning to conceive/father children during the study.
- History of allogenic tissue or solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
A
Amy Rose, RN, BSN
CONTACT
D
Danielle L Bednarz, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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