RecruitingPhase 2NCT05578326
Official study title

Study of Trilaciclib and Lurbinectidin

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTrilaciclib and Lurbinectedin

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Drug: Trilaciclib; Drug: Lurbinectedin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
  • 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
  • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel HillChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2026. Always confirm current availability with the study team.

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