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NCT Number: NCT07473128

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

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.

Recruiting

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Key information

Conditions

Limited Stage Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pharmacosmos Investigational Site

Oakland, California, 48073, United States

Location status: Recruiting

Location contact

Pharmacosmos A/S Clinical and non-clinical research

CONTACT

[email protected]

455-948-5959

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Trilaciclib

Drug

Intravenous infusion

Saline (0.9% NaCl)

Drug

Intravenous infusion

Other names: dextrose

Primary outcomes

  1. To Compare trilaciclib to placebo on prevention of myelosuppression

    Time frame: From enrollment and 4 months after

    Duration and occurrence of severe neutropenia

Secondary outcomes

  1. Number of all-cause chemotherapy dose reductions

    Time frame: From enrollment and 4 months after

  2. Occurrence of granulocyte colony-stimulating factor (G-CSF) administration

    Time frame: From enrollment and 4 months after

  3. Number of hospitalizations due to myelosuppression or sepsis

    Time frame: From enrollment and 4 months after

  4. Number of febrile neutropenia

    Time frame: From enrollment and 4 months after

  5. Occurrence of red blood cell (RBC) transfusions

    Time frame: From enrollment and 4 months after

Study contacts

Contact information is provided by the study sponsor or research team.

Pharmacosmos A/S Clinical and non-clinical research

CONTACT

[email protected]

+4559485959

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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