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Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:
Phase II Feasibility Study of Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC

Clinical Trial Summary

This study is to determine if a fecal microbiota transplant (FMT) improves the body's ability to fight cancer in patients with relapsed/refractory PD-L1 Positive NSCLC.

Clinical Trial Description

The study evaluating the addition of R-FMT 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 R-FMT (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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05669846
Study type Interventional
Source University of Pittsburgh
Contact Amy Rose, RN, BSN
Phone 412-647-8587
Email kennaj@upmc.edu
Status Not yet recruiting
Phase Phase 2
Start date July 31, 2024
Completion date July 31, 2029
View Details
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