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

NCT05874401 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

  • Extensive-stage Small-cell Lung Cancer

Interventions

DRUG

Trilaciclib

Participants will receive intravenous trilaciclib infusion

DRUG

Placebo

Participants will receive intravenous placebo infusion

DRUG

Topotecan

Participants will receive intravenous topotecan infusion

Sponsors & Collaborators

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Pharmacosmos Clinical and non-clinical Department · Pharmacosmos A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2027-10-30
Completion
2027-10-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874401 on ClinicalTrials.gov