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

Purpose

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.

Condition

  • Limited Stage Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Trilaciclib 		Receives trilaciclib
  • Drug: Trilaciclib
    Intravenous infusion
Placebo Comparator
Placebo 		Receives placebo
  • Drug: Saline (0.9% NaCl)
    Intravenous infusion
    Other names:
    • dextrose

Recruiting Locations

Pharmacosmos Investigational Site
Oakland, California 48073
Contact:
Pharmacosmos A/S Clinical and non-clinical research
455-948-5959
info@pharmacosmos.com

More Details

Status
Recruiting
Sponsor
Pharmacosmos A/S

Study Contact

Pharmacosmos A/S Clinical and non-clinical research
+4559485959
info@pharmacosmos.com