Recruiting
Phase 2

Trilaciclib & Lurbinectidin

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05578326

Conditions

Lung Cancer

Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trilaciclib

Lurbinectedin

Study Details

Brief 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.

Conditions

Lung Cancer

Small-cell Lung Cancer

Study ID

NCT05578326

Start date

Oct 12, 2022

Status verified date

Mar, 2026

Completion date

Dec 25, 2028

Anticipated

Primary completion date

Dec 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trilaciclib and Lurbinectedin

Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin

Interventions

Trilaciclib

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

Lurbinectedin

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

Primary outcome measure

  • The proportion of grade 4 neutropenia [ Time Frame: Up to 21 days ]
  • The duration of grade 4 neutropenia [ Time Frame: Up to 21 days ]

Central Contacts and Locations

Central contacts

Shamina Williams

919-966-4432shamina_williams@med.unc.edu

Lauren Higgins

919-966-4432Lauren_Higgins@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Jared Weiss, MD

919-843-7718jared_weiss@med.unc.edu

Lauren Higgins

lqhiggin@ad.unc.edu

Principal Investigator:

Jared Weiss, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Lurbinectedin
  • Trilaciclib
  • myelosuppression
  • neutropenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-03-30.