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ACTIVE NOT RECRUITING
NCT07881705
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

Trilaciclib

Trilaciclib at 240mg/m\^2;

OTHER

Trilaciclib Placebo

250 mL of 5% dextrose in water or normal saline (0.9% sodium chloride solution)

DRUG

Etoposide Injection

Etoposide Injection at dose level of 100 mg/m\^2

DRUG

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.

RADIATION

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