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

NCT07473128 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: LS-SCLC-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To Compare trilaciclib to placebo on prevention of myelosuppression

  Duration and occurrence of severe neutropenia

  From enrollment and 4 months after

Secondary Outcomes (5)

• 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

Study Arms (2)

Trilaciclib

EXPERIMENTAL

Receives trilaciclib

Drug: Trilaciclib

Placebo

PLACEBO COMPARATOR

Receives placebo

Drug: Saline (0.9% NaCl)

Interventions

Saline (0.9% NaCl) DRUG

Intravenous infusion

Also known as: dextrose

Placebo

Trilaciclib DRUG

Intravenous infusion

Trilaciclib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Pharmacosmos Investigational Site

Oakland, California, 48073, United States

RECRUITING

MeSH Terms

Interventions

trilaciclib; Sodium Chloride; Glucose

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Pharmacosmos A/S Clinical and non-clinical research

CONTACT

+4559485959; info@pharmacosmos.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)