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ATLANTIS: a Phase III study of lurbinectedin/doxorubicin versus topotecan or cyclophosphamide/doxorubicin/vincristine in patients with small-cell lung cancer who have failed one prior platinum-containing line.
Farago, Anna F; Drapkin, Benjamin J; Lopez-Vilarino de Ramos, Jose Antonio; Galmarini, Carlos M; Núñez, Rafael; Kahatt, Carmen; Paz-Ares, Luis.
Afiliação
  • Farago AF; Harvard Medical School, Boston, MA 02115, USA.
  • Drapkin BJ; Massachusetts General Hospital Cancer Center, Boston, MA 02114, USA.
  • Lopez-Vilarino de Ramos JA; Massachusetts General Hospital Cancer Center, Boston, MA 02114, USA.
  • Galmarini CM; PharmaMar, Colmenar Viejo, Madrid, Spain.
  • Núñez R; PharmaMar, Colmenar Viejo, Madrid, Spain.
  • Kahatt C; PharmaMar, Colmenar Viejo, Madrid, Spain.
  • Paz-Ares L; PharmaMar, Colmenar Viejo, Madrid, Spain.
Future Oncol ; 15(3): 231-239, 2019 Jan.
Article em En | MEDLINE | ID: mdl-30362375
ABSTRACT
Lurbinectedin is an inhibitor of active transcription of protein-coding genes, causing DNA-break accumulation, apoptosis and modulation of the tumor microenvironment. Early-phase clinical trials indicate promising activity of lurbinectedin in small-cell lung cancer. Here, we describe the rationale and design of ATLANTIS (NCT02566993), an open-label, randomized, multicenter Phase III study to compare the efficacy of lurbinectedin and doxorubicin combination with standard-of-care chemotherapy, investigator's choice of cyclophosphamide/doxorubicin/vincristine or topotecan, in patients with small-cell lung cancer that has progressed following one line of platinum-based chemotherapy. Patients are randomized in a 11 ratio. The primary end point is overall survival and key secondary end points include progression-free survival, best tumor response and duration of response, each assessed by independent review committee.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carbolinas / Doxorrubicina / Carcinoma de Pequenas Células do Pulmão / Microambiente Tumoral / Compostos Heterocíclicos de 4 ou mais Anéis Tipo de estudo: Clinical_trials Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Future Oncol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carbolinas / Doxorrubicina / Carcinoma de Pequenas Células do Pulmão / Microambiente Tumoral / Compostos Heterocíclicos de 4 ou mais Anéis Tipo de estudo: Clinical_trials Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Future Oncol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos