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Study of Trilaciclib and Lurbinectedin for Small Cell Lung Cancer

This study is looking at how two medications, Trilaciclib and Lurbinectedin, work together for people with small cell lung cancer. Small cell lung cancer is a serious type of lung cancer. Lurbinectedin is already approved for use, but this study wants to see if adding Trilaciclib can help. Researchers will give Trilaciclib intravenously (into a vein) over 30 minutes and Lurbinectedin intravenously over 60 minutes, both on day 1 of each treatment cycle. The main goal is to see how many participants experience severe low white blood cell counts (grade 4 neutropenia) and for how long. This helps understand the safety of the combination. About 30 adults aged 18 and older can join this study. The current recruitment status is unclear.

Study design
This study plans to enroll about 30 participants. The specific phase of the study is not mentioned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track severe low white blood cell counts for up to 21 days.

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NCT05578326

Study of Trilaciclib and Lurbinectidin

Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~30 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:TrilaciclibLurbinectedin

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of grade 4 neutropenia
Measured over Up to 21 days
+1 more outcome measured

Conditions

Lung Cancer
Small-cell Lung Cancer

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

2 sites across 2 states
New Hampshire1
North Carolina1

Study leadership

  • Jared Weiss, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Shamina Williams
[email protected]
919-966-4432
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The proportion of grade 4 neutropeniaUp to 21 days

    The proportion of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be determined. CTCAE is descriptive terminology that can be used for Adverse Event (AE) grading and reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  • The duration of grade 4 neutropeniaUp to 21 days

    The median duration of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be reported.