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NCT05578326 · ClinicalTrials.gov registry record · Phase 2

Study of Trilaciclib and Lurbinectidin

A Phase 2 study of Lung Cancer and Small-cell Lung Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
2
Study locations

NCT05578326 is a Phase 2 study of Lung Cancer and Small-cell Lung Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 30 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05578326, a Phase 2 study of Lung Cancer and Small-cell Lung Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
2
Study locations

Study Summary

Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression. This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.

Conditions Studied

Lung Cancer Small-cell Lung Cancer

Interventions

  • DRUG Lurbinectedin
  • DRUG Trilaciclib

Study Locations (2)

New Hampshire

  • Dartmouth Hitchcock Medical Center - Lebanon

North Carolina

  • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-10-12
Est. Completion 2027-12-25
Phase Phase 2

Sponsor

UNC Lineberger Comprehensive Cancer Center

366 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05578326

The ClinicalTrials.gov registry entry for NCT05578326 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Lurbinectedin is the first listed.

NCT05578326 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New Hampshire, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05578326 about?

NCT05578326 is a clinical study titled "Study of Trilaciclib and Lurbinectidin". Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and ...

What is the current status of trial NCT05578326?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-10-12. Estimated completion is 2027-12-25.

What conditions does trial NCT05578326 study?

This clinical trial studies the following conditions: Lung Cancer, Small-cell Lung Cancer.

What interventions are being tested in trial NCT05578326?

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

Who is sponsoring clinical trial NCT05578326?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05578326 being conducted?

This trial has 2 study locations across New Hampshire, North Carolina. 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.