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RECRUITING
NCT05578326
PHASE2

Study of Trilaciclib and Lurbinectidin

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-10-12

Completion Date

2028-12-25

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Trilaciclib

240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle

DRUG

Lurbinectedin

3.2 mg/m2, over 60 minutes at day 1 of each cycle

Locations (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States