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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

231

Study ID:

NCT01828112

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 94 Locations for this study

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Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Memorial Cancer Institute SC
Hollywood Florida, 33021, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
University of Miami SC
Miami Florida, 33136, United States
Loyola University Medical Center /Cardinal Bernardin Cancer SC
Maywood Illinois, 60153, United States
University of Iowa Hospitals and Clinics Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Massachusetts General Hospital SC-8
Boston Massachusetts, 02114, United States
Oklahoma Cancer Specialists and Research Institute SC-2
Tulsa Oklahoma, 74136, United States
Sarah Cannon Research Institute SC-5
Nashville Tennessee, 37203, United States
Texas Oncology-Sugarland
Sugar Land Texas, 77479, United States
Texas Oncology Cancer Care and Research Center
Waco Texas, 76712, United States
Virginia Cancer Specialists SC Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Swedish Cancer Institute SC-1
Seattle Washington, 98104, United States
Novartis Investigative Site
Edegem Antwerpen, 2650, Belgium
Novartis Investigative Site
Bruxelles , 1000, Belgium
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Toronto Ontario, M5G 2, Canada
Novartis Investigative Site
Marseille cedex 20 Bouches Du Rhone, 13915, France
Novartis Investigative Site
Le Mans Cedex 09, 72037, France
Novartis Investigative Site
Besancon cedex , 25030, France
Novartis Investigative Site
Brest , 29200, France
Novartis Investigative Site
Caen Cedex , 14021, France
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Mulhouse cedex , 68070, France
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Paris , 75970, France
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Strasbourg , F 670, France
Novartis Investigative Site
Suresnes , 92150, France
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Bad Berka , 99437, Germany
Novartis Investigative Site
Essen , 45147, Germany
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Esslingen , 73730, Germany
Novartis Investigative Site
Frankfurt , 60590, Germany
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Heidelberg , 69120, Germany
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Koeln , 51109, Germany
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Tübingen , 72076, Germany
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Ulm , 89081, Germany
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Hong Kong , , Hong Kong
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Limerick Co Limerick, , Ireland
Novartis Investigative Site
Dublin 4 , , Ireland
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Kfar Saba , 44281, Israel
Novartis Investigative Site
Ramat Gan , 52621, Israel
Novartis Investigative Site
Avellino AV, 83100, Italy
Novartis Investigative Site
Monza MB, 20900, Italy
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Milano MI, 20132, Italy
Novartis Investigative Site
Perugia PG, 06129, Italy
Novartis Investigative Site
Pisa PI, 56124, Italy
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Aviano PN, 33081, Italy
Novartis Investigative Site
Reggio Emilia RE, 42123, Italy
Novartis Investigative Site
Roma RM, 00189, Italy
Novartis Investigative Site
Orbassano TO, 10043, Italy
Novartis Investigative Site
Verona VR, 37126, Italy
Novartis Investigative Site
Nagoya Aichi, 464 8, Japan
Novartis Investigative Site
Kashiwa Chiba, 277 8, Japan
Novartis Investigative Site
Fukuoka city Fukuoka, 812-8, Japan
Novartis Investigative Site
Fukuoka-city Fukuoka, 811-1, Japan
Novartis Investigative Site
Akashi Hyogo, 673-8, Japan
Novartis Investigative Site
Okayama-city Okayama, 700-8, Japan
Novartis Investigative Site
Hirakata-city Osaka, 573-1, Japan
Novartis Investigative Site
Osaka Sayama Osaka, 589 8, Japan
Novartis Investigative Site
Osaka-city Osaka, 541-8, Japan
Novartis Investigative Site
Takatsuki-city Osaka, 569-8, Japan
Novartis Investigative Site
Koto ku Tokyo, 135 8, Japan
Novartis Investigative Site
Niigata , 951 8, Japan
Novartis Investigative Site
Seoul Korea, 05505, Korea, Republic of
Novartis Investigative Site
Seoul Seocho Gu, 06591, Korea, Republic of
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Ashrafieh , 16683, Lebanon
Novartis Investigative Site
Amsterdam , 1081 , Netherlands
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Groningen , 9713 , Netherlands
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Lisboa , 1649 , Portugal
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Moscow , 11547, Russian Federation
Novartis Investigative Site
Moscow , 14342, Russian Federation
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Saint Petersburg , 19702, Russian Federation
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Singapore , 11922, Singapore
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Singapore , 16961, Singapore
Novartis Investigative Site
Sevilla Andalucia, 41013, Spain
Novartis Investigative Site
Sevilla Andalucia, 41017, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
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Barcelona Cataluña, 08028, Spain
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Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
La Coruna Galicia, 15006, Spain
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Santiago de Compostela Galicia, 15706, Spain
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Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Madrid , 28046, Spain
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Madrid , 28222, Spain
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Luzern , 6000, Switzerland
Novartis Investigative Site
St. Gallen , 9007, Switzerland
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Istanbul TUR, 34098, Turkey
Novartis Investigative Site
Ankara , 06100, Turkey
Novartis Investigative Site
Pendik / Istanbul , 34899, Turkey
Novartis Investigative Site
Cheltenham Gloucestershire, GL53 , United Kingdom
Novartis Investigative Site
Hants Southampton, SO9 5, United Kingdom
Novartis Investigative Site
Aberdeen , AB25 , United Kingdom
Novartis Investigative Site
Leicester , LE1 5, United Kingdom
Novartis Investigative Site
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

231

Study ID:

NCT01828112

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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