RecruitingPhase 4NCT05874401

Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy


Sponsor

Pharmacosmos A/S

Enrollment

302 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called trilaciclib can protect the bone marrow of people with advanced small cell lung cancer who are receiving a chemotherapy called topotecan. Trilaciclib works by temporarily putting bone marrow cells to sleep during chemotherapy, which may reduce harmful side effects like low blood cell counts. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer (a type of lung cancer that has spread) - Your cancer has progressed during or after one or two previous chemotherapy regimens - Your first chemotherapy included a platinum-based drug - Your cancer has at least one measurable spot on scans **You may NOT be eligible if...** - You have previously received topotecan or trilaciclib - You had chemotherapy, immunotherapy, or other cancer treatment within the past 3 weeks - You have brain metastases that need immediate radiation or steroids - You had radiation therapy within the past 2 weeks - You have a history of lung inflammation (ILD/pneumonitis) - You have another active cancer within the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib

Participants will receive intravenous trilaciclib infusion

DRUGPlacebo

Participants will receive intravenous placebo infusion

DRUGTopotecan

Participants will receive intravenous topotecan infusion


Locations(1)

Hospital

Seville, Spain

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NCT05874401


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