Effect of Trilaciclib in the Prevention of Myelosupressio... | NCT07473128

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

NCT07473128

Sponsor

Pharmacosmos A/S

Status

Recruiting

Last Update Posted

Jun 17, 2026Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Limited Stage Small Cell Lung Cancer

Interventions

Trilaciclib
Saline (0.9% NaCl)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2026Estimated

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Mar 5, 2026

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trilaciclib	Experimental	Receives trilaciclib	Drug: Trilaciclib
Placebo	Placebo Comparator	Receives placebo	Drug: Saline (0.9% NaCl)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trilaciclib	Drug	Intravenous infusion	Trilaciclib
Saline (0.9% NaCl)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pharmacosmos A/S Clinical and non-clinical research	Contact	+4559485959		info@pharmacosmos.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pharmacosmos Investigational Site	Recruiting	Oakland	California	48073	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000708352	trilaciclib
D012965	Sodium Chloride
D005947	Glucose

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided