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

March 10, 2026 updated by: Pharmacosmos A/S

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trilaciclib
Receives trilaciclib
Drug: Trilaciclib
Intravenous infusion
Placebo Comparator: Placebo
Receives placebo
Drug: Saline (0.9% NaCl)
Intravenous infusion
Other Names:
  • dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Compare trilaciclib to placebo on prevention of myelosuppression
Time Frame: From enrollment and 4 months after
Duration and occurrence of severe neutropenia
From enrollment and 4 months after

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of all-cause chemotherapy dose reductions
Time Frame: From enrollment and 4 months after
From enrollment and 4 months after
Occurrence of granulocyte colony-stimulating factor (G-CSF) administration
Time Frame: From enrollment and 4 months after
From enrollment and 4 months after
Number of hospitalizations due to myelosuppression or sepsis
Time Frame: From enrollment and 4 months after
From enrollment and 4 months after
Number of febrile neutropenia
Time Frame: From enrollment and 4 months after
From enrollment and 4 months after
Occurrence of red blood cell (RBC) transfusions
Time Frame: From enrollment and 4 months after
From enrollment and 4 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacosmos A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS-SCLC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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