Lung Cancer Clinical Trial
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Summary
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.
Eligibility Criteria
Inclusion Criteria:
Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.
Exclusion Criteria:
Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
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There are 94 Locations for this study
Fayetteville Arkansas, 72703, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32256, United States
Miami Florida, 33136, United States
Maywood Illinois, 60153, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02114, United States
Tulsa Oklahoma, 74136, United States
Nashville Tennessee, 37203, United States
Sugar Land Texas, 77479, United States
Waco Texas, 76712, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98104, United States
Edegem Antwerpen, 2650, Belgium
Bruxelles , 1000, Belgium
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Toronto Ontario, M5G 2, Canada
Marseille cedex 20 Bouches Du Rhone, 13915, France
Le Mans Cedex 09, 72037, France
Besancon cedex , 25030, France
Brest , 29200, France
Caen Cedex , 14021, France
Mulhouse cedex , 68070, France
Paris , 75970, France
Strasbourg , F 670, France
Suresnes , 92150, France
Bad Berka , 99437, Germany
Essen , 45147, Germany
Esslingen , 73730, Germany
Frankfurt , 60590, Germany
Heidelberg , 69120, Germany
Koeln , 51109, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Hong Kong , , Hong Kong
Limerick Co Limerick, , Ireland
Dublin 4 , , Ireland
Kfar Saba , 44281, Israel
Ramat Gan , 52621, Israel
Avellino AV, 83100, Italy
Monza MB, 20900, Italy
Milano MI, 20132, Italy
Perugia PG, 06129, Italy
Pisa PI, 56124, Italy
Aviano PN, 33081, Italy
Reggio Emilia RE, 42123, Italy
Roma RM, 00189, Italy
Orbassano TO, 10043, Italy
Verona VR, 37126, Italy
Nagoya Aichi, 464 8, Japan
Kashiwa Chiba, 277 8, Japan
Fukuoka city Fukuoka, 812-8, Japan
Fukuoka-city Fukuoka, 811-1, Japan
Akashi Hyogo, 673-8, Japan
Okayama-city Okayama, 700-8, Japan
Hirakata-city Osaka, 573-1, Japan
Osaka Sayama Osaka, 589 8, Japan
Osaka-city Osaka, 541-8, Japan
Takatsuki-city Osaka, 569-8, Japan
Koto ku Tokyo, 135 8, Japan
Niigata , 951 8, Japan
Seoul Korea, 05505, Korea, Republic of
Seoul Seocho Gu, 06591, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Ashrafieh , 16683, Lebanon
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Lisboa , 1649 , Portugal
Moscow , 11547, Russian Federation
Moscow , 14342, Russian Federation
Saint Petersburg , 19702, Russian Federation
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Sevilla Andalucia, 41013, Spain
Sevilla Andalucia, 41017, Spain
Barcelona Catalunya, 08035, Spain
Barcelona Cataluña, 08028, Spain
Valencia Comunidad Valenciana, 46010, Spain
La Coruna Galicia, 15006, Spain
Santiago de Compostela Galicia, 15706, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28222, Spain
Luzern , 6000, Switzerland
St. Gallen , 9007, Switzerland
Istanbul TUR, 34098, Turkey
Ankara , 06100, Turkey
Pendik / Istanbul , 34899, Turkey
Cheltenham Gloucestershire, GL53 , United Kingdom
Hants Southampton, SO9 5, United Kingdom
Aberdeen , AB25 , United Kingdom
Leicester , LE1 5, United Kingdom
London , SE1 9, United Kingdom
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