CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 613 enrolled
Drug / intervention
Lurbinectedin (PM01183) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02566993
NCT02566993Phase 3Completed

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)

PharmaMar·interventional·Posted Oct 2, 2015·Updated Oct 28, 2021

In Brief

A Phase 3 clinical trial evaluating Lurbinectedin (PM01183), Doxorubicin (DOX), and 3 other interventions for Small-cell Lung Cancer. Completed, enrolled 613 participants across 160 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, Poland, Portugal, Romania, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2, 2015
Enrollment StartAug 30, 2016
Primary CompletionFeb 24, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.8 years ago

Interventions

Lurbinectedin (PM01183)drug

Doxorubicin (DOX)drug

Cyclophosphamide (CTX)drug

Vincristine (VCR)drug

Topotecandrug