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.
Not a woman of childbearing potential (WOCBP); OR
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.
Histologically or cytologically confirmed diagnosis of stage IV PD-L1+ NSCLC.
NOTE: Patients with either squamous or non-squamous NSCLC may enroll.
Diagnosis of NSCLC histologies other than squamous and/or adenocarcinoma histologies including small cell, large cell, neuroendocrine and/or sarcomatoid histologies.
Receipt of prior agent(s) targeting the intestinal microbiome including but not limited to: FMT, defined bacterial consortia, single bacterial species and/or microbiota derived peptides.
Prior chemotherapy, targeted therapy, and/or small molecule therapy within 2 weeks (or 4 half lives) prior to study Day 1.
Prior radiotherapy within 2 weeks of start of study intervention.
Diwakar Davar
Lead sponsor
University of Pittsburgh
Sponsor institution
Gateway for Cancer Research
Collaborator