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

Official Title

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 (ATLANTIS Trial)

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 to determine a difference in progression-free survival (PFS) by an Independent Review Committee (IRC) between lurbinectedin (PM01183)/doxorubicin (DOX) and the control arm (CAV) or topotecan and to analyze the median overall survival (OS) and mid- and long-term overall survival (OS at 12, 18 and 24 months).

Trial Description

Primary Outcome:

  • Progression-free survival (PFS)
Secondary Outcome:
  • Overall survival (OS)
  • Overall survival rate 12, 18 & 24 months

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society