Study on Healthy Donor FMT and Pembrolizumab for Relapsed/Refractory PD-L1 Positive Lung Cancer

Sponsor: Diwakar Davar

Sponsor score: 0

ClinicalTrials ID:NCT05669846

Provider View

This clinical trial is exploring whether using healthy donor fecal microbiota transplantation (FMT) can enhance the body's ability to fight lung cancer in patients whose cancer has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if adding healthy donor FMT to the cancer drug pembrolizumab can help the immune system better fight lung cancer that is PD-L1 positive and has either come back or not responded to treatment. The trial will last for about two years, and patients will receive both FMT and pembrolizumab. The FMT will be given through procedures like colonoscopy and sigmoidoscopy, while pembrolizumab will be administered every three weeks. The treatment will continue until the cancer progresses, side effects become too severe, or the two-year period is completed.

Description

This study is testing a new approach to treating PD-L1 positive non-small cell lung cancer (NSCLC) that has returned or not responded to previous treatments. It involves using healthy donor fecal microbiota transplantation (FMT) along with the cancer drug pembrolizumab. The trial will last for 104 weeks, and patients will be selected if their cancer has progressed after receiving PD-1 therapy. Participants will be matched with a suitable donor who has responded well to PD-1 therapy. The FMT will be given through colonoscopy and sigmoidoscopy at specific intervals, and pembrolizumab will be administered every three weeks. The study will continue until the cancer progresses, side effects become intolerable, or the two-year treatment period is completed.

Eligibility Criteria

Inclusion Criteria

  • Male participants must agree to use contraception and not donate sperm during treatment and for 120 days after the last dose.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • Must have stage IV PD-L1 positive non-small cell lung cancer (NSCLC).
  • Cancer must have progressed after treatment with anti-PD-1 or PD-L1 therapy.
  • Patients with stable brain metastases can participate if they meet specific criteria.
  • Must be willing to receive FMT through procedures like colonoscopy and sigmoidoscopy.
  • Must have measurable disease and be able to provide a tumor biopsy.
  • Must have good overall health and organ function.
  • Patients with hepatitis B or C must have controlled viral loads and be on antiviral therapy.

Exclusion Criteria

  • Have a type of lung cancer other than squamous or adenocarcinoma.
  • Have received certain microbiome-targeting therapies before.
  • Have had recent chemotherapy, targeted therapy, or radiation therapy.
  • Have severe allergies or conditions that prevent FMT.
  • Have not recovered from previous treatment side effects.
  • Have received a live vaccine recently.
  • Have an active autoimmune disease requiring treatment.
  • Have another active cancer or untreated brain metastases.
  • Have severe allergies to pembrolizumab or similar drugs.
  • Have active infections like HIV, hepatitis B, or C.
  • Have a history of severe heart or lung conditions.
  • Have psychiatric or substance abuse issues that affect participation.
  • Are pregnant, breastfeeding, or planning to have children during the study.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center15232PittsburghPennsylvania

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.