RecruitingPhase 3NCT06496048

Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)


Sponsor

Luye Pharma Group Ltd.

Enrollment

180 participants

Start Date

Sep 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment options — lurbinectedin (alone or with irinotecan) versus topotecan — for people with small cell lung cancer (SCLC) that has come back after initial treatment. **You may be eligible if...** - You are 18 or older with confirmed small cell lung cancer - Your cancer has returned after one prior treatment regimen with etoposide and a platinum drug (with or without immunotherapy) - You are in reasonably good physical condition (ECOG 0–2) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have received more than one prior line of treatment for SCLC - You have uncontrolled brain metastases - You have severe bone marrow, liver, or kidney problems - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLurbinectedin

Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)

DRUGIrinotecan

Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk

DRUGLurbinectedin

Lurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)

DRUGTopotecan

Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk


Locations(1)

Jilin Provincial Tumor Hospital

Jilin, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06496048


Related Trials