20 Participants Needed

Nadofaragene Firadenovec for Transitional Cell Carcinoma

(LUNAR Trial)

GC
Overseen ByGlobal Clinical Compliance
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

GC

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

My doctor believes I have more than 2 years to live.
I am a man who will use birth control or am sterile if my partner can get pregnant.
I can sign and understand the consent form.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

A safety lead-in period for the first 6 subjects to evaluate safety and tolerability

3 months

Treatment

Participants receive Nadofaragene Firadenovec instilled to the renal pelvis

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nadofaragene Firadenovec
Trial Overview The trial tests the safety and tolerability of Nadofaragene Firadenovec in patients with LG-UTUC. The first six participants will go through a safety lead-in period. Success is measured by the complete absence of UTUC in the renal pelvis at either 3 or 6 months after treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials
323
Recruited
1,242,000+
Pierre-Yves Berclaz profile image

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 profile image

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

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