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
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.
Arms & interventions
- DrugTrilaciclib
Intravenous infusion
- DrugSaline (0.9% NaCl)
Intravenous infusion
Outcome measures
Primary
To Compare trilaciclib to placebo on prevention of myelosuppression
Duration and occurrence of severe neutropenia
Time frame: From enrollment and 4 months after
Secondary
Number of all-cause chemotherapy dose reductions
Time frame: From enrollment and 4 months after
Occurrence of granulocyte colony-stimulating factor (G-CSF) administration
Time frame: From enrollment and 4 months after
Number of hospitalizations due to myelosuppression or sepsis
Time frame: From enrollment and 4 months after
Number of febrile neutropenia
Time frame: From enrollment and 4 months after
Occurrence of red blood cell (RBC) transfusions
Time frame: From enrollment and 4 months after
Eligibility criteria
Study locations (1)
Pharmacosmos Investigational Site
Oakland, California, 48073