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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

Keywords

Non-Small Cell Lung Cancer ALK LDK378 Non-small cell lung carcinoma (NSCLC) treatment of lung cancer after first metastasis lung cancer lung adenocarcinoma Non small cell lung carcinoma Non small cell lung cancer NSCLC chemotherapy ALK-positive ALK-rearranged advanced non-small cell lung cancer crizotinib Lung Neoplasms Carcinoma, Non-Small-Cell Lung Docetaxel Ceritinib Pemetrexed

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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.
  2. 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.
  3. 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
  4. Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.

You CAN'T join if...

  1. Patient with known hypersensitivity to any of the excipients of LDK378(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  3. 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.

Locations

  • University of California San Francisco Dept. of UCSF
    San Francisco, California, 94101, United States
  • Arizona Oncology Associates PC- HAL
    Sedona, Arizona, 86336, United States
  • Wenatchee Valley Medical Center SC
    Wenatchee, Washington, 98801, United States
  • Swedish Cancer Institute SC-1
    Seattle, Washington, 98104, United States
  • Oklahoma Cancer Specialists and Research Institute SC-2
    Tulsa, Oklahoma, 74136, United States
  • Texas Oncology Cancer Care & Research Center
    Waco, Texas, 76712, United States
  • Highlands Oncology Group Satellite 1
    Fayetteville, Arkansas, 72703, United States
  • Texas Oncology-Sugarland
    Sugar Land, Texas, 77479, United States
  • University of Iowa Hospitals & Clinics Comprehensive Cancer Center
    Iowa City, Iowa, 52242, United States
  • Loyola University Medical Center /Cardinal Bernardin Cancer SC
    Maywood, Illinois, 60153, United States
  • Sarah Cannon Research Institute SC-5
    Nashville, Tennessee, 37203, United States
  • Novartis Investigative Site
    Toronto, Ontario, M5G 2M9, Canada
  • Cancer Specialists of North Florida
    Jacksonville, Florida, 32256, United States
  • Virginia Cancer Specialists SC Virginia Cancer Specialists
    Fairfax, Virginia, 22031, United States
  • Memorial Cancer Institute SC
    Hollywood, Florida, 33021, United States
  • University of Miami SC
    Miami, Florida, 33136, United States
  • Massachusetts General Hospital SC-8
    Boston, Massachusetts, 02114, United States
  • Novartis Investigative Site
    Limerick, Co Limerick, Ireland
  • Novartis Investigative Site
    Dublin 4, Ireland
  • Novartis Investigative Site
    Moscow, 115478, Russian Federation
  • Novartis Investigative Site
    Moscow, 143423, Russian Federation
  • Novartis Investigative Site
    Saint Petersburg, 197022, Russian Federation
  • Novartis Investigative Site
    Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
  • Novartis Investigative Site
    Hants, Southampton, SO9 5NY, United Kingdom
  • Novartis Investigative Site
    Aberdeen, AB25 2ZN, United Kingdom
  • Novartis Investigative Site
    Leicester, LE1 5WW, United Kingdom
  • Novartis Investigative Site
    London, SE1 9RT, United Kingdom
  • Novartis Investigative Site
    Manchester, M20 2BX, United Kingdom
  • Novartis Investigative Site
    Nagoya, Aichi, 464-8681, Japan
  • Novartis Investigative Site
    Kashiwa, Chiba, 277-8577, Japan
  • Novartis Investigative Site
    Fukuoka city, Fukuoka, 812-8582, Japan
  • Novartis Investigative Site
    Akashi, Hyogo, 673-8558, Japan
  • Novartis Investigative Site
    Niigata-city, Niigata, 951-8520, Japan
  • Novartis Investigative Site
    Okayama-city, Okayama, 700-8558, Japan
  • Novartis Investigative Site
    Hirakata-city, Osaka, 573-1191, Japan
  • Novartis Investigative Site
    Osaka City, Osaka, 541-8567, Japan
  • Novartis Investigative Site
    OsakaSayama, Osaka, 589-8511, Japan
  • Novartis Investigative Site
    Takatsuki-city, Osaka, 569-8686, Japan
  • Novartis Investigative Site
    Koto, Tokyo, 135-8550, Japan
  • Novartis Investigative Site
    Fukuoka, 811-1395, Japan
  • Novartis Investigative Site
    Amsterdam, 1081 HV, Netherlands
  • Novartis Investigative Site
    Groningen, 9713 GZ, Netherlands
  • Novartis Investigative Site
    Maastricht, 6229 HX, Netherlands
  • Novartis Investigative Site
    Bruxelles, 1000, Belgium
  • Novartis Investigative Site
    Bruxelles, 1200, Belgium
  • Novartis Investigative Site
    Edegem, 2650, Belgium
  • Novartis Investigative Site
    Leuven, 3000, Belgium
  • Novartis Investigative Site
    Coimbra, 3041-853, Portugal
  • Novartis Investigative Site
    Lisboa, 1649-035, Portugal
  • Novartis Investigative Site
    Seoul, Korea, 03080, Korea, Republic of
  • Novartis Investigative Site
    Seoul, Korea, 05505, Korea, Republic of
  • Novartis Investigative Site
    Seoul, Korea, 06351, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 03722, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 06591, Korea, Republic of
  • Novartis Investigative Site
    Besancon cedex, 25030, France
  • Novartis Investigative Site
    Brest, 29200, France
  • Novartis Investigative Site
    Caen Cedex, 14021, France
  • Novartis Investigative Site
    Le Mans Cedex 09, 72037, France
  • Novartis Investigative Site
    Lille Cedex, 59020, France
  • Novartis Investigative Site
    Marseille cedex 20, 13915, France
  • Novartis Investigative Site
    Mulhouse cedex, 68070, France
  • Novartis Investigative Site
    Paris, 75015, France
  • Novartis Investigative Site
    Paris, 75970, France
  • Novartis Investigative Site
    Strasbourg, F-67085, France
  • Novartis Investigative Site
    Suresnes, 92150, France
  • Novartis Investigative Site
    Bad Berka, 99437, Germany
  • Novartis Investigative Site
    Berlin, 13125, Germany
  • Novartis Investigative Site
    Essen, 45147, Germany
  • Novartis Investigative Site
    Esslingen, 73730, Germany
  • Novartis Investigative Site
    Frankfurt, 60590, Germany
  • Novartis Investigative Site
    Grosshansdorf, 22947, Germany
  • Novartis Investigative Site
    Heidelberg, 69120, Germany
  • Novartis Investigative Site
    Koeln, 51109, Germany
  • Novartis Investigative Site
    Tuebingen, 72076, Germany
  • Novartis Investigative Site
    Ulm, 89081, Germany
  • Novartis Investigative Site
    Sevilla, Andalucia, 41013, Spain
  • Novartis Investigative Site
    Sevilla, Andalucia, 41017, Spain
  • Novartis Investigative Site
    Sabadell, Barcelona, 08208, Spain
  • Novartis Investigative Site
    Barcelona, Catalunya, 08035, Spain
  • Novartis Investigative Site
    Hospitalet de LLobregat, Catalunya, 08907, Spain
  • Novartis Investigative Site
    Barcelona, Cataluña, 08028, Spain
  • Novartis Investigative Site
    Valencia, Comunidad Valenciana, 46010, Spain
  • Novartis Investigative Site
    La Coruna, Galicia, 15006, Spain
  • Novartis Investigative Site
    Santiago de Compostela, Galicia, 15706, Spain
  • Novartis Investigative Site
    Majadahonda, Madrid, 28222, Spain
  • Novartis Investigative Site
    Madrid, 28034, Spain
  • Novartis Investigative Site
    Madrid, 28041, Spain
  • Novartis Investigative Site
    Madrid, 28046, Spain
  • Novartis Investigative Site
    Luzern, 6000, Switzerland
  • Novartis Investigative Site
    St. Gallen, 9007, Switzerland
  • Novartis Investigative Site
    Avellino, AV, 83100, Italy
  • Novartis Investigative Site
    Monza, MB, 20900, Italy
  • Novartis Investigative Site
    Milano, MI, 20132, Italy
  • Novartis Investigative Site
    Perugia, PG, 06129, Italy
  • Novartis Investigative Site
    Pisa, PI, 56124, Italy
  • Novartis Investigative Site
    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
    Hong Kong, Hong Kong
  • Novartis Investigative Site
    Ankara, 06100, Turkey
  • Novartis Investigative Site
    Fatih / Istanbul, 34098, Turkey
  • Novartis Investigative Site
    Pendik / Istanbul, 34899, Turkey
  • Novartis Investigative Site
    Beirut, 166830, Lebanon
  • Novartis Investigative Site
    Kfar-Saba, 4428164, Israel
  • Novartis Investigative Site
    Petach Tikva, 49100, Israel
  • Novartis Investigative Site
    Ramat Gan, 5265601, Israel
  • Novartis Investigative Site
    Singapore, 119228, Singapore
  • Novartis Investigative Site
    Singapore, 169610, Singapore

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01828112
Phase
Phase 3
Study Type
Interventional
Last Updated
August 3, 2017