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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: Active Phase 2 study of Advanced Non-Small-Cell Lung Cancer and Advanced Urothelial Carcinoma, sponsored by Fujifilm Pharmaceuticals U.S.A..

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs) and to confirm dose (RP2D) of FF-10832 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 solid tumors.

Conditions Studied

Advanced Non-Small-Cell Lung Cancer Advanced Urothelial Carcinoma

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

FieldValue
Enrollment Target 120 participants
Start Date 2022-06-01
Est. Completion 2029-11
Phase Phase 2
Fujifilm Pharmaceuticals U.S.A.

8 total trials

What the registry record for NCT05318573 still lists

NCT05318573 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 377-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (68% lower).

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 names 20 study sites across 16 states, led by 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.

Learn More About Clinical Trials

Similar trials for Advanced Non-Small-Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05318573's enrollment target sits among peer trials

120 16th of 22 higher than 7 of 22 other Advanced Non-Small-Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Non-Small-Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05318573, the US trial registry maintained by the National Library of Medicine. NCT05318573 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.