Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (ATLANTIS)
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|ClinicalTrials.gov Identifier: NCT02566993|
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer||Drug: Lurbinectedin (PM01183) Drug: Doxorubicin (DOX) Drug: Cyclophosphamide (CTX) Drug: Vincristine (VCR) Drug: Topotecan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||613 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||August 30, 2016|
|Actual Primary Completion Date :||February 2020|
|Actual Study Completion Date :||February 2020|
Experimental: Experimental Arm
Lurbinectedin (PM01183) / Doxorubicin
Drug: Lurbinectedin (PM01183)
Drug: Doxorubicin (DOX)
Active Comparator: Control Arm 1
CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
Drug: Doxorubicin (DOX)
Drug: Cyclophosphamide (CTX)
Drug: Vincristine (VCR)
Active Comparator: Control Arm 2
- Overall survival (OS) [ Time Frame: Every three months up to death or study termination (aprox. 10 months) ]Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
- Progression-free survival (PFS) [ Time Frame: Every six weeks up to progression disease (aprox. 5 months) ]Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
- Best antitumor response [ Time Frame: Every three months up to death or study termination (aprox. 24 months) ]Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566993