NCT02566993

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

Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lurbinectedin (PM01183)
DRUG	Doxorubicin (DOX)
DRUG	Cyclophosphamide (CTX)
DRUG	Vincristine (VCR)
DRUG	Topotecan

Timeline

• Start date: 2016-08-30
• Primary completion: 2020-02-24
• Completion: 2020-02-24
• First posted: 2015-10-02
• Last updated: 2021-10-28
• Results posted: 2021-10-28

Locations

160 sites across 20 countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, Poland, Portugal, Romania, Spain, United Kingdom