NCT05669846

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Diwakar Davar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study evaluating the addition of Healthy Donor FMT (hdFMT) to pembrolizumab in PD-1 R/R NSCLC will be conducted over a 104-week period. Patients with anti-PD-1 R/R NSCLC are eligible to enroll. Prior exposure to microbiome modulating therapy is exclusionary. Suitable patients will be identified at the time of progression upon PD-1 monotherapy or PD-1 containing regimens. Patients will undergo a 35-day screening evaluation consisting of systemic staging scans, tumor biopsy, stool/blood serologic studies to confirm suitability. Once enrolled, patients will be seromatched with a suitable donor. Suitable donors are advanced cancer patients who have undergone PD-1 monotherapy and are currently in durable remission (median PFS \>24 months from initiation of PD-1 therapy) with no ongoing irAE as delineated below. Patients will receive Healthy Donor FMT (hdFMT) (induction) via colonoscopy on C1D1 and C3D1. R-FMT (maintenance) via sigmoidoscopy on C4D1 and will be repeated every 9 weeks. All patients will additionally receive pembrolizumab at 200mg every three weeks. Patients will be treated until disease progression or intolerable toxicity or completion of 2 years of therapy, whichever comes first.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Healthy Donor Fecal Microbiota Transplant (hdFMT)	FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by performing a colonoscopy and sigmoidoscopy, or, administered orally in the form of capsules. The FMT consists of introducing normal bacterial flora contained in the stool collected from a healthy donor into the small intestine. In this case, the hdFMT will be administered 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.
DRUG	Pembrolizumab	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.

Timeline

• Start date: 2025-01-08
• Primary completion: 2036-12-31
• Completion: 2036-12-31
• First posted: 2023-01-03
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study