Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trilaciclib, Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Limited Stage Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Trilaciclib
Intravenous infusion - Drug Saline (0.9% NaCl)
Intravenous infusion
Primary outcome measures
- To Compare trilaciclib to placebo on prevention of myelosuppression [Time frame: From enrollment and 4 months after]
Secondary outcome measures (5)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Pharmacosmos Investigational Site — Oakland
Identifiers
NCT: NCT07473128 · LS-SCLC-01