Nadofaragene Firadenovec for Transitional Cell Carcinoma
(LUNAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.
Who Is on the Research Team?
Global Clinical Compliance
Principal Investigator
Ferring Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with low-grade upper tract urothelial cancer (LG-UTUC) who can consent, have a measurable tumor of 5-15 mm after possible downsizing, confirmed diagnosis within 2 months, an ECOG status ≤2, and a life expectancy >2 years. Women must test negative for pregnancy and use effective contraception or be postmenopausal/surgically sterile; men must also agree to use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
A safety lead-in period for the first 6 subjects to evaluate safety and tolerability
Treatment
Participants receive Nadofaragene Firadenovec instilled to the renal pelvis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nadofaragene Firadenovec
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ferring Pharmaceuticals
Lead Sponsor
Pierre-Yves Berclaz
Ferring Pharmaceuticals
Chief Medical Officer since 2023
MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine
Jean-Frédéric Paulsen
Ferring Pharmaceuticals
Chief Executive Officer since 2023
Master’s degree in Finance from the London School of Economics and Political Science