LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Inclusion criteria:
Exclusion criteria:
Ciudad Autónoma de Bs As, C1180AAX, Argentina
Ciudad Autónoma de Bs As, C1426ANZ, Argentina
Købenahvn Ø, 2100, Denmark
Großhansdorf, 22927, Germany
Homburg/Saar, 66421, Germany
Fukuoka, Kitakyushu, 807-8556, Japan
Hyogo, Amagasaki, 660-8550, Japan
Hyogo, Nishinomiya, 663-8501, Japan
Kanagawa , Yokosuka, 238-8558, Japan
Okayama, Okayama, 702-8055, Japan
Osaka, OsakaSayama, 589-8511, Japan
Osaka, Osaka, 540-0008, Japan
Tokyo, Bunkyo-ku, 113-8431, Japan
Saint Petersburg, 197758, Russia