TY - JOUR
T1 - ATLANTIS
T2 - 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
AU - Farago, Anna F.
AU - Drapkin, Benjamin J.
AU - Lopez-Vilarino De Ramos, Jose Antonio
AU - Galmarini, Carlos M.
AU - Núñez, Rafael
AU - Kahatt, Carmen
AU - Paz-Ares, Luis
N1 - Funding Information:
AF Farago received consulting fees from PharmaMar, Bayer, Loxo, Abbvie, Abbvie/Stemcentrx and Genentech. The author further received research funding from PharmaMar, Bayer, Loxo, AbbVie, AbbVie/Stemcentrx, Merck, BMS, AstraZeneca and Novartis. BJ Drapkin received research funding from AstraZeneca, Novartis and AbbVie. JAL-Vilarino de Ramos, CM Golmarini, R Nunez, C Kahatt are employees of PharmaMar. L Paz-Ares gave scientific advice to Astra-Zeneca, BMS, MSD, Roche, Incyte, Takeda, Lilly, Novartis, Pfizer, Pharmamar, Amgen and Genomica. The manuscript arose, in whole or in part, from direct costs funded by NIH (grant number: K12 CA087723). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Funding Information:
Here, we describe the design and rationale for the ATLANTIS study (NCT02566993), an open-label, randomized Phase III trial to evaluate efficacy and safety of lurbinectedin and doxorubicin combination versus investigator’s choice chemotherapy, either topotecan or CAV, in patients with SCLC who have failed one prior platinum-containing line. The study is funded by Pharma Mar SA, Madrid, Spain.
Publisher Copyright:
© 2018 Future Medicine Ltd.
PY - 2019/1
Y1 - 2019/1
N2 - 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 1:1 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.
AB - 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 1:1 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.
KW - Phase III trial
KW - lurbinectedin
KW - small-cell lung cancer
KW - targeting transcription
UR - http://www.scopus.com/inward/record.url?scp=85058895314&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058895314&partnerID=8YFLogxK
U2 - 10.2217/fon-2018-0597
DO - 10.2217/fon-2018-0597
M3 - Article
C2 - 30362375
AN - SCOPUS:85058895314
SN - 1479-6694
VL - 15
SP - 231
EP - 239
JO - Future Oncology
JF - Future Oncology
IS - 3
ER -