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NCT05318573 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer
A Phase 2 study of Advanced Non-Small-Cell Lung Cancer and Advanced Urothelial Carcinoma, sponsored by Fujifilm Pharmaceuticals U.S.A..
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05318573 is a Phase 2 study of Advanced Non-Small-Cell Lung Cancer and Advanced Urothelial Carcinoma that is active but no longer recruiting, run by Fujifilm Pharmaceuticals U.S.A.. The registered enrollment target is 120 participants, below the 377-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT05318573, a Phase 2 study of Advanced Non-Small-Cell Lung Cancer and Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by Fujifilm Pharmaceuticals U.S.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG FF-10832
Study Locations (20)
California
- Cancer and Blood Speciality Clinic - Long Beach
- Sharp Memorial Hospital (Oncology Clinical Research) - San Diego
Kentucky
- University of Kentucky Medical Center - Lexington
- University of Louisville Brown Cancer Center - Louisville
New York
- NYU Langone Health - New York
- Icahn School of Medicine at Mount Sinai - New York
Pennsylvania
- Hospital of the Univ of Pennsylvania Perlman Center - Philadelphia
- UPMC Hillman Cancer Center - Pittsburgh
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Kansas
- University of Kansas Cancer Center - Westwood - Westwood
Michigan
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) - Detroit
Missouri
- Washington University School of Medicine, Center for Adv Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2029-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05318573
The ClinicalTrials.gov registry entry for NCT05318573 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (68% lower). The listed sponsor is Fujifilm Pharmaceuticals U.S.A., which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05318573 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Kentucky, New York.
Frequently Asked Questions
What is clinical trial NCT05318573 about?
NCT05318573 is a clinical study titled "A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer". To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer
What is the current status of trial NCT05318573?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-06-01. Estimated completion is 2029-11.
What conditions does trial NCT05318573 study?
This clinical trial studies the following conditions: Advanced Non-Small-Cell Lung Cancer, Advanced Urothelial Carcinoma.
What interventions are being tested in trial NCT05318573?
The interventions under investigation include: Pembrolizumab (DRUG), FF-10832 (DRUG).
Who is sponsoring clinical trial NCT05318573?
This trial is sponsored by Fujifilm Pharmaceuticals U.S.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05318573 being conducted?
This trial has 20 study locations across California, District of Columbia, Kansas, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.