drugset / Trial / 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)

NCT05153239

Phase 3 Completed 705 enrolled PharmaMar
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-22
Primary completion
2026-04-10
Completion
2026-04-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Irinotecan Small molecule 75 mg/m2 Intravenous
Comparator Irinotecan Small molecule 300 mg/m2 Intravenous
Comparator Irinotecan Small molecule 350 mg/m2 Intravenous
Subject Lurbinectedin Other / unclassified 2 mg/m2 Intravenous
Subject Lurbinectedin Other / unclassified 3.2 mg/m2 Intravenous
Comparator Topotecan Small molecule 1.5 mg/m2 Oral
Comparator Topotecan Small molecule 2.3 mg/m2 Oral