Study of Trilaciclib and Lurbinectidin

UNC Lineberger Comprehensive Cancer Center

Status and phase

Enrolling

Phase 2

Conditions

Small-cell Lung Cancer

Lung Cancer

Treatments

Drug: Lurbinectedin

Drug: Trilaciclib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05578326

LCCC2117

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 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.