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
Pharmacosmos A/S
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
Interventions
- DrugTrilaciclib
Intravenous infusion
- DrugSaline (0.9% NaCl)
Intravenous infusion
Location
- Pharmacosmos Investigational SiteOakland, California