Recruiting
Phase 3

Trilaciclib

Sponsor:

Pharmacosmos A/S

Code:

NCT07473128

Conditions

Limited Stage Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trilaciclib

Saline (0.9% NaCl)

Study Details

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

Study ID

NCT07473128

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Trilaciclib

Receives trilaciclib

placebo comparator: Placebo

Receives placebo

Interventions

Trilaciclib

Intravenous infusion

Saline (0.9% NaCl)

Intravenous infusion

Primary outcome measure

  • To Compare trilaciclib to placebo on prevention of myelosuppression [ Time Frame: From enrollment and 4 months after ]

Central Contacts and Locations

Central contacts

Pharmacosmos A/S Clinical and non-clinical research

+4559485959info@pharmacosmos.com

Locations

Pharmacosmos Investigational Site

Recruiting

Oakland, California, United States, 48073

Contacts

Pharmacosmos A/S Clinical and non-clinical research

+4559485959info@pharmacosmos.com

More Information

Sponsor

Pharmacosmos A/S

Last update posted

Oct 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Pharmacosmos A/S on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.