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Clinical Trial 18835
Interventions:Adriamycin (doxorubicin); PM01183 (lurbinectedin); Topotecan; Vincristine; cyclophosphamide; cytoxan (cyclophosphamide); doxorubicin
Study Type: Treatment
Phase of Study: Phase III
- Alberto Chiappori
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)
The main purpose of this clinical trial is to know if lurbinectedin (PM01183) when administered in combination with doxorubicin (DOX) is superior to the currently available standard treatment [topotecan, or a combination of cyclophosphamide (CTX), DOX and vincristine (VCR) known as CAV] in controlling small cell lung cancer (SCLC) evolution in patients who had progressed after receiving a platinum-containing line of treatment. Also the global effects (good or bad) of this combination will be compared to those of topotecan, a drug used and approved to treat this condition in the United States, the European Union and most Western countries. The knowledge obtained from this treatment combination may provide a way to fight against this type of cancer in a more specific way.
Primary: To determine a difference in progression-free survival PFS) by an Independent Review Committee IRC)between lurbinectedin (PM01183)/doxorubicin (DOX)and a control arm consisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)and vincristine (VCR) CAV) or topotecan, as treatment in SCLC patients after failure of one prior platinumcontaining line. Secondary: To analyze: Overall survival (OS). Mid- and long-term survival (OS at 12, 18 and 24 months, respectively). Efficacy and safety profiles in the subgroups of thePM01183/DOX arm vs. CAV or topotecan. PFS by Investigators Assessment (IA). Antitumor activity according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. Safety profile. Patient-reported outcomes (PRO). Pharmacokinetics (PK) of the combination in patients treated in the experimental arm (PM01183/DOX). PK/pharmacodynamic (PDy) correlations in theexperimental arm, if any. Pharmacogenetics of known polymorphisms in patients treated in the experimental arm.