RecruitingPhase 3NCT07473128

Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer


Sponsor

Pharmacosmos A/S

Enrollment

120 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is: Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer? Participants will be randomised to receive either trilaciclib or placebo.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Confirmed diagnosis of Limited-Stage Small Cell Lung Cancer
  • Complete recovery from prior anti-tumor surgical procedures
  • Measurable and evaluable disease through tumor assessment
  • Willingness to participate and sign informed consent form

Exclusion Criteria4

  • Extensive Stage Small Cell Lung Cancer
  • Active cardiovascular disease
  • Known hypersensitivity to trilaciclib, etoposide, carboplatin, cisplatin or any component in their formulations
  • Pregnant or nursing women

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Interventions

DRUGTrilaciclib

Intravenous infusion

DRUGSaline (0.9% NaCl)

Intravenous infusion


Locations(1)

Pharmacosmos Investigational Site

Oakland, California, United States

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NCT07473128


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