About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Trilaciclib
DrugIntravenous infusion
Saline (0.9% NaCl)
DrugIntravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
To Compare trilaciclib to placebo on prevention of myelosuppression
Duration and occurrence of severe neutropenia
Secondary outcomes
Number of all-cause chemotherapy dose reductions
Occurrence of granulocyte colony-stimulating factor (G-CSF) administration
Number of hospitalizations due to myelosuppression or sepsis
Number of febrile neutropenia
Sponsors and contacts
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