LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients With Unresectable Malignant Pleural Mesothelioma.
Identifieur interne : 000910 ( Main/Exploration ); précédent : 000909; suivant : 000911LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients With Unresectable Malignant Pleural Mesothelioma.
Auteurs : Giorgio V. Scagliotti [Italie] ; Rabab Gaafar [Égypte] ; Anna K. Nowak [Australie] ; Martin Reck [Allemagne] ; Anne S. Tsao [États-Unis] ; Jan Van Meerbeeck [Belgique] ; Nicholas J. Vogelzang [États-Unis] ; Takashi Nakano [Japon] ; Ute Von Wangenheim [Allemagne] ; Derek Velema [Canada] ; Nassim Morsli [France] ; Sanjay Popat [Royaume-Uni]Source :
- Clinical lung cancer [ 1938-0690 ] ; 2017.
Abstract
Malignant pleural mesothelioma (MPM) is a rare but aggressive disease: median survival is 6 to 9 months if untreated. Standard first-line treatment for patients with unresectable MPM is cisplatin/pemetrexed, with a median overall survival (OS) of approximately 1 year. Improvements in first-line treatment options are needed. With the benefit of combining bevacizumab with standard therapy shown in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS), vascular endothelial growth factor (VEGF) pathway inhibition has gained renewed interest as a treatment approach. Nintedanib is an oral angiokinase inhibitor targeting multiple signaling pathways implicated in the pathogenesis of MPM, including the VEGF receptor. The phase III part of the international, phase II/III LUME-Meso study is evaluating the efficacy and safety of nintedanib plus pemetrexed/cisplatin in patients with unresectable epithelioid MPM. Originally, this was a double-blind, randomized, phase II exploratory study and was amended to include a confirmatory phase III part following the recommendation of an internal Data Monitoring Committee and review of phase II data. The phase III part plans to enroll 450 chemotherapy-naive patients, who will be randomized to receive pemetrexed/cisplatin on day 1 and nintedanib or placebo on days 2 to 21, for a maximum of 6 cycles. Patients without disease progression who are eligible to continue study treatment will receive maintenance treatment with nintedanib or placebo until disease progression or undue toxicity. The primary end point is progression-free survival; OS is the key secondary end point. The study will use an adaptive design, including an interim analysis to reassess the number of OS events required to ensure sufficient power for OS analysis. The study is currently enrolling patients.
DOI: 10.1016/j.cllc.2017.03.010
PubMed: 28690011
Affiliations:
- Allemagne, Australie, Belgique, Canada, France, Italie, Japon, Royaume-Uni, Égypte, États-Unis
- Nevada, Piémont, Texas, Île-de-France
- Paris, Turin
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Scagliotti</name><affiliation wicri:level="3"><nlm:affiliation>Department of Oncology, University of Turin, S Luigi Hospital, Torino, Italy. Electronic address: giorgio.scagliotti@unito.it.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Oncology, University of Turin, S Luigi Hospital, Torino</wicri:regionArea><placeName><settlement type="city">Turin</settlement><region type="région" nuts="2">Piémont</region></placeName></affiliation></author><author><name sortKey="Gaafar, Rabab" sort="Gaafar, Rabab" uniqKey="Gaafar R" first="Rabab" last="Gaafar">Rabab Gaafar</name><affiliation wicri:level="1"><nlm:affiliation>National Cancer Institute, Cairo University, Cairo, Egypt.</nlm:affiliation><country xml:lang="fr">Égypte</country><wicri:regionArea>National Cancer Institute, Cairo University, Cairo</wicri:regionArea><wicri:noRegion>Cairo</wicri:noRegion></affiliation></author><author><name sortKey="Nowak, Anna K" sort="Nowak, Anna K" uniqKey="Nowak A" first="Anna K" last="Nowak">Anna K. Nowak</name><affiliation wicri:level="1"><nlm:affiliation>School of Medicine, Faculty of Medicine and Health Sciences, University of Western Australia, Crawley, Western Australia, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medicine, Faculty of Medicine and Health Sciences, University of Western Australia, Crawley, Western Australia, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia</wicri:regionArea><wicri:noRegion>Western Australia</wicri:noRegion></affiliation></author><author><name sortKey="Reck, Martin" sort="Reck, Martin" uniqKey="Reck M" first="Martin" last="Reck">Martin Reck</name><affiliation wicri:level="1"><nlm:affiliation>Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf</wicri:regionArea><wicri:noRegion>Grosshansdorf</wicri:noRegion><wicri:noRegion>Grosshansdorf</wicri:noRegion><wicri:noRegion>Grosshansdorf</wicri:noRegion></affiliation></author><author><name sortKey="Tsao, Anne S" sort="Tsao, Anne S" uniqKey="Tsao A" first="Anne S" last="Tsao">Anne S. Tsao</name><affiliation wicri:level="2"><nlm:affiliation>Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center, Houston, TX.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Van Meerbeeck, Jan" sort="Van Meerbeeck, Jan" uniqKey="Van Meerbeeck J" first="Jan" last="Van Meerbeeck">Jan Van Meerbeeck</name><affiliation wicri:level="1"><nlm:affiliation>Department of Thoracic Oncology, Antwerp University Hospital, Edegem, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Thoracic Oncology, Antwerp University Hospital, Edegem</wicri:regionArea><wicri:noRegion>Edegem</wicri:noRegion></affiliation></author><author><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J" last="Vogelzang">Nicholas J. Vogelzang</name><affiliation wicri:level="2"><nlm:affiliation>US Oncology Comprehensive Cancer Centers of Nevada, Las Vegas, NV.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Nevada</region></placeName><wicri:cityArea>US Oncology Comprehensive Cancer Centers of Nevada, Las Vegas</wicri:cityArea></affiliation></author><author><name sortKey="Nakano, Takashi" sort="Nakano, Takashi" uniqKey="Nakano T" first="Takashi" last="Nakano">Takashi Nakano</name><affiliation wicri:level="1"><nlm:affiliation>Division of Respiratory Medicine, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Division of Respiratory Medicine, Department of Internal Medicine, Hyogo College of Medicine, Hyogo</wicri:regionArea><wicri:noRegion>Hyogo</wicri:noRegion></affiliation></author><author><name sortKey="Von Wangenheim, Ute" sort="Von Wangenheim, Ute" uniqKey="Von Wangenheim U" first="Ute" last="Von Wangenheim">Ute Von Wangenheim</name><affiliation wicri:level="1"><nlm:affiliation>Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co KG, Biberach</wicri:regionArea><wicri:noRegion>Biberach</wicri:noRegion><wicri:noRegion>Biberach</wicri:noRegion><wicri:noRegion>Biberach</wicri:noRegion></affiliation></author><author><name sortKey="Velema, Derek" sort="Velema, Derek" uniqKey="Velema D" first="Derek" last="Velema">Derek Velema</name><affiliation wicri:level="1"><nlm:affiliation>Boehringer Ingelheim (Canada) Ltd/Ltée, Burlington, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Boehringer Ingelheim (Canada) Ltd/Ltée, Burlington, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Morsli, Nassim" sort="Morsli, Nassim" uniqKey="Morsli N" first="Nassim" last="Morsli">Nassim Morsli</name><affiliation wicri:level="3"><nlm:affiliation>Boehringer Ingelheim France S.A.S., Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Boehringer Ingelheim France S.A.S., Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Popat, Sanjay" sort="Popat, Sanjay" uniqKey="Popat S" first="Sanjay" last="Popat">Sanjay Popat</name><affiliation wicri:level="1"><nlm:affiliation>Royal Marsden Hospital NHS Foundation Trust, London and Surrey, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Marsden Hospital NHS Foundation Trust, London and Surrey</wicri:regionArea><wicri:noRegion>London and Surrey</wicri:noRegion></affiliation></author></analytic><series><title level="j">Clinical lung cancer</title><idno type="eISSN">1938-0690</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Malignant pleural mesothelioma (MPM) is a rare but aggressive disease: median survival is 6 to 9 months if untreated. Standard first-line treatment for patients with unresectable MPM is cisplatin/pemetrexed, with a median overall survival (OS) of approximately 1 year. Improvements in first-line treatment options are needed. With the benefit of combining bevacizumab with standard therapy shown in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS), vascular endothelial growth factor (VEGF) pathway inhibition has gained renewed interest as a treatment approach. Nintedanib is an oral angiokinase inhibitor targeting multiple signaling pathways implicated in the pathogenesis of MPM, including the VEGF receptor. The phase III part of the international, phase II/III LUME-Meso study is evaluating the efficacy and safety of nintedanib plus pemetrexed/cisplatin in patients with unresectable epithelioid MPM. Originally, this was a double-blind, randomized, phase II exploratory study and was amended to include a confirmatory phase III part following the recommendation of an internal Data Monitoring Committee and review of phase II data. The phase III part plans to enroll 450 chemotherapy-naive patients, who will be randomized to receive pemetrexed/cisplatin on day 1 and nintedanib or placebo on days 2 to 21, for a maximum of 6 cycles. Patients without disease progression who are eligible to continue study treatment will receive maintenance treatment with nintedanib or placebo until disease progression or undue toxicity. The primary end point is progression-free survival; OS is the key secondary end point. The study will use an adaptive design, including an interim analysis to reassess the number of OS events required to ensure sufficient power for OS analysis. The study is currently enrolling patients.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>France</li><li>Italie</li><li>Japon</li><li>Royaume-Uni</li><li>Égypte</li><li>États-Unis</li></country><region><li>Nevada</li><li>Piémont</li><li>Texas</li><li>Île-de-France</li></region><settlement><li>Paris</li><li>Turin</li></settlement></list><tree><country name="Italie"><region name="Piémont"><name sortKey="Scagliotti, Giorgio V" sort="Scagliotti, Giorgio V" uniqKey="Scagliotti G" first="Giorgio V" last="Scagliotti">Giorgio V. Scagliotti</name></region></country><country name="Égypte"><noRegion><name sortKey="Gaafar, Rabab" sort="Gaafar, Rabab" uniqKey="Gaafar R" first="Rabab" last="Gaafar">Rabab Gaafar</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Nowak, Anna K" sort="Nowak, Anna K" uniqKey="Nowak A" first="Anna K" last="Nowak">Anna K. Nowak</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Reck, Martin" sort="Reck, Martin" uniqKey="Reck M" first="Martin" last="Reck">Martin Reck</name></noRegion><name sortKey="Von Wangenheim, Ute" sort="Von Wangenheim, Ute" uniqKey="Von Wangenheim U" first="Ute" last="Von Wangenheim">Ute Von Wangenheim</name></country><country name="États-Unis"><region name="Texas"><name sortKey="Tsao, Anne S" sort="Tsao, Anne S" uniqKey="Tsao A" first="Anne S" last="Tsao">Anne S. Tsao</name></region><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J" last="Vogelzang">Nicholas J. Vogelzang</name></country><country name="Belgique"><noRegion><name sortKey="Van Meerbeeck, Jan" sort="Van Meerbeeck, Jan" uniqKey="Van Meerbeeck J" first="Jan" last="Van Meerbeeck">Jan Van Meerbeeck</name></noRegion></country><country name="Japon"><noRegion><name sortKey="Nakano, Takashi" sort="Nakano, Takashi" uniqKey="Nakano T" first="Takashi" last="Nakano">Takashi Nakano</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Velema, Derek" sort="Velema, Derek" uniqKey="Velema D" first="Derek" last="Velema">Derek Velema</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Morsli, Nassim" sort="Morsli, Nassim" uniqKey="Morsli N" first="Nassim" last="Morsli">Nassim Morsli</name></region></country><country name="Royaume-Uni"><noRegion><name sortKey="Popat, Sanjay" sort="Popat, Sanjay" uniqKey="Popat S" first="Sanjay" last="Popat">Sanjay Popat</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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