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NCT06088290 · ClinicalTrials.gov registry record · Phase 3

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

A Phase 3 study of Leiomyosarcoma, sponsored by PharmaMar.

Recruiting
Registry status
Phase 3
Development phase
450
Enrollment target
20
Study locations

NCT06088290 is a Phase 3 study of Leiomyosarcoma that is actively recruiting participants, run by PharmaMar. The registered enrollment target is 450 participants, above the 94-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (379% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT06088290, a Phase 3 study of Leiomyosarcoma, is actively recruiting participants, sponsored by PharmaMar.

RECRUITING
Registry status
Phase 3
Development phase
450 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this phase III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

Conditions Studied

Leiomyosarcoma

Interventions

  • DRUG Doxorubicin
  • DRUG Lurbinectedin

Study Locations (20)

California

  • Precision NextGen Oncology & Research Center - Beverly Hills
  • Cedars-Sinai Medical Center - Los Angeles
  • Norris Comprehensive Cancer Center - Los Angeles
  • Sarcoma Oncology Center - Los Angeles
  • Stanford University (Leland Stanford Junior University) - Palo Alto

Florida

  • Mayo Clinic - Jacksonville - Jacksonville
  • Moffitt Cancer Center - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Arizona

  • Mayo Clinic Hospital - Phoenix - Phoenix

Colorado

  • University of Colorado Hospital - Anschutz Medical Campus - Aurora

Georgia

  • Augusta University Georgia Cancer Center - Augusta

Michigan

  • University of Michigan - Ann Arbor

Minnesota

  • Mayo Clinic - Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2023-09-21
Est. Completion 2029-08-30
Phase Phase 3

Sponsor

PharmaMar

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06088290

The ClinicalTrials.gov registry entry for NCT06088290 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 94-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (379% higher). The listed sponsor is PharmaMar, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Doxorubicin is the first listed.

NCT06088290 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06088290 about?

NCT06088290 is a clinical study titled "Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)". The primary objective of this phase III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin adm...

What is the current status of trial NCT06088290?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2023-09-21. Estimated completion is 2029-08-30.

What conditions does trial NCT06088290 study?

This clinical trial studies the following conditions: Leiomyosarcoma.

What interventions are being tested in trial NCT06088290?

The interventions under investigation include: Doxorubicin (DRUG), Lurbinectedin (DRUG).

Who is sponsoring clinical trial NCT06088290?

This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06088290 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.