Study of Trilaciclib and Lurbinectidin

Last updated: June 27, 2024
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Lung Cancer

Non-small Cell Lung Cancer

Treatment

Trilaciclib

Lurbinectedin

Clinical Study ID

NCT05578326
LCCC2117
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

  • Written informed consent obtained to participate in the study and HIPAAauthorization for release of personal health information.

  • Age ≥ 18 years at the time of consent.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

  • Measurable disease according to RECIST v1.1 within 28 days prior to start oftreatment.

  • Previous treatment with a platinum agent, PD1 or PDL1 agent.

Exclusion

Exclusion Criteria:

  • Active infection requiring systemic therapy.

  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future usewhile the mother is being treated on study).

  • Treatment with any investigational drug within 4 weeks prior to start oftreatment.

  • A known allergy or sensitivity to either study drug or its excipients.

  • Subject is receiving prohibited medications or treatments as listed in theprotocol.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Trilaciclib
Phase: 2
Study Start date:
October 12, 2022
Estimated Completion Date:
December 25, 2027

Connect with a study center

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

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

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

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