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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: Recruiting Phase 2 study of Lung Cancer and Small-cell Lung Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be determined. CTCAE is descriptive terminology that can be used for Adverse Event (AE) grading and reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate inst
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2027-12-25 |
| Phase | Phase 2 |
What NCT05578326 shows while recruiting
NCT05578326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05578326's enrollment target sits among peer trials
30 318th of 409 higher than 80 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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