NCT05153239

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 705 (estimated)
• Sponsor: PharmaMar · 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 as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

Detailed description

Approximately 705 Adult SCLC patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 who have failed one prior platinum-containing line with CTFI ≥ 30 days and controlled asymptomatic and pretreated Central Nervous System metastases will be enrolled and assigned to each treatment arm. Central randomization will be implemented; patients will be assigned to each treatment arm at a 1:1:1 ratio. An Independent Data Monitoring Committee (IDMC) will oversee the conduct of the study. The IDMC should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits.

Conditions

• Relapsed Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
DRUG	Lurbinectedin	Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
DRUG	Irinotecan	For patients aged \<70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk
DRUG	Topotecan	Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk
DRUG	Lurbinectedin	Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk

Timeline

• Start date: 2022-07-22
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-12-10
• Last updated: 2026-03-09

Locations

210 sites across 24 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Denmark, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Poland, Romania, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study