Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC (NCT05669846)

🧪 Interventions in This Study

• Healthy Donor Fecal Microbiota Transplant (hdFMT) (DRUG)
• Pembrolizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Male participants:
2. A male participant must agree to use a contraception as detailed per protocol of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
3. Female participants:
4. A female participant is eligible to participate if she is not pregnant per protocol, not breastfeeding, and at least one of the following conditions applies:
5. Not a woman of childbearing potential (WOCBP); OR
6. A WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and for at least 120 days after the last dose of study treatment.
7. Histologically or cytologically confirmed diagnosis of stage IV PD-L1+ NSCLC.
8. NOTE: Patients with either squamous or non-squamous NSCLC may enroll.
9. NOTE: 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 (fine needle aspirate is not sufficient).
10. NOTE: Patients with small cell, large cell, neuroendocrine and/or sarcomatoid NSCLC are excluded.
11. 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. PD-1 treatment progression is defined by meeting all the following criteria:
12. Has received at least 2 doses of an approved anti-PD(L)1 ICI administered as a single agent, in combination with chemotherapy, and/or in combination with other investigational therapy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania

📞 Contact the Study Coordinator

Phone: (412) 647-8587

Email: kennaj@upmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Patients will receive Healthy Donor FMT (hdFMT) (induction) via colonoscopy on C1D1 and C3D1.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.