NCT06496048

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lurbinectedin	Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
DRUG	Irinotecan	Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
DRUG	Lurbinectedin	Lurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
DRUG	Topotecan	Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk

Timeline

• Start date: 2024-09-14
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-07-11
• Last updated: 2024-12-12

Locations

1 site across 1 country: China