Study of Trilaciclib and Lurbinectidin

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05578326

Patient View

This study evaluates Trilaciclib's impact on myelosuppression in patients with platinum-refractory ES-SCLC receiving Lurbinectedin. Eligible participants are adults with ECOG 0-1, measurable disease, and prior platinum/PD1/PDL1 treatment. Exclusions include active infections and recent investigational drug use. Interventions involve Trilaciclib (240 mg/m²) and Lurbinectedin (3.2 mg/m²) administered intravenously.

Patient Parameters

Program Overview

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 Criteria

  • Written informed consent obtained to participate in the study and HIPAA authorization 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 of treatment.
  • Previous treatment with a platinum agent, PD1 or PDL1 agent.

Exclusion Criteria

  • Active infection requiring systemic therapy.

    • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
    • Treatment with any investigational drug within 4 weeks prior to start of treatment.
    • A known allergy or sensitivity to either study drug or its excipients.
    • Subject is receiving prohibited medications or treatments as listed in the protocol.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.