drugset / Trial / NCT06496048
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
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 monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
Timeline
- Start
- 2024-09-14
- Primary completion
- 2027-12-31
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 2 mg/m2 | Other |
| Subject | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | Other |
| Comparator | Topotecan | Small molecule | 1.2 mg/m2 | Intravenous |