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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |