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A Phase III, Randomized, Double-blind, Multi-center Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
The primary goal of this study is to evaluate the myelo-protective effect and safety of Trilaciclib in participants with limited stage small cell lung cancer (LS-SCLC) who are receiving concurrent chemo-radiotherapy. Researchers will compare Trilaciclib with placebo (a look-alike substance that contains no drug) to see if Trilaciclib works better in protecting the participant's marrow function while receiving concurrent chemo-radiotherapy.
Official title: The Randomized, Double-blind, Multi-center Phase III Clinical Trial of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer Receiving Concurrent Chemo-radiotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2026-06-17
Completion Date
2027-09-30
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Trilaciclib
Trilaciclib at 240mg/m\^2;
Trilaciclib Placebo
250 mL of 5% dextrose in water or normal saline (0.9% sodium chloride solution)
Etoposide Injection
Etoposide Injection at dose level of 100 mg/m\^2
Carboplatin or Cisplatin Injection
Use Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most); Cisplatin at a dose level of 75 mg/m\^2.
Radiotherapy
30-33 days of totally 60-66 Gy for QD radiation, or 15 days of totally 45 Gy for BID radiation.
Locations (1)
Shandong Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China