drugset / Trial / NCT02566993

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

NCT02566993

Phase 3 Completed 613 enrolled PharmaMar
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

EvaluationDrugModalityDoseRoute
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