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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07473128

Enrollment

120

Registered

2026-03-16

Start date

2026-06-30

Completion date

2027-06-01

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limited Stage Small Cell Lung Cancer

Brief 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.

Interventions

DRUGTrilaciclib

Intravenous infusion

DRUGSaline (0.9% NaCl)

Intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTPharmacosmos A/S Clinical and non-clinical research

info@pharmacosmos.com+4559485959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026