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

Detailed 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

Interventions

Drug
Trilaciclib
Intravenous infusion
Drug
Saline (0.9% NaCl)
Intravenous infusion

Location

Pharmacosmos Investigational Site
Oakland, California
info@pharmacosmos.com +4559485959

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

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions