drugset / Trial / NCT02566993
Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.
Timeline
- Start
- 2016-08-30
- Primary completion
- 2020-02-24
- Completion
- 2020-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 45 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 2 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 1.5 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 2 mg | Intravenous |