| ClinicalTrials Identifier: | NCT02566993 |
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| Updated: | 2016_04_04 |
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 Descriptive Information
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| Brief title | 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 |
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| 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) |
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| Brief summary |
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| 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). |
| Detailed description |
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| Phase | Phase 3 |
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| Study type | Interventional |
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| Study design | Treatment |
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| Study design | Randomized
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Administrative Data
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| Organization name | PharmaMar |
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| Organization study ID | PM1183-C-003-14 |
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| Sponsor | PharmaMar |
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| Health Authority | United States: Food and Drug Administration |
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Recruitment
Information :
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| Status : | Not yet recruiting
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| Start date : | 2016-06
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Primary completion date :
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2019-06 (Anticipated)
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