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A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Sponsor: Hoffmann-La Roche
Summary
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
Official title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
303
Start Date
2014-08-19
Completion Date
2025-04-28
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
Alectinib
Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Crizotinib
Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Locations (97)
North Valley Hem Onc Med Grp
Northridge, California, United States
TMPN/ Cancer Care Associates
Redondo Beach, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Miami-Deerfield Beach
Deerfield Beach, Florida, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Dana Farber Can Ins
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington Uni School of Medicine
St Louis, Missouri, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Monash Health Translational Precinct
Victoria, Victoria, Australia
University Clinical Center Sarajevo
Sarajevo, Bosnia and Herzegovina
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Centro Internacional de Estudios Clínicos (CIEC)
Santiago, Chile
Sun Yet-sen University Cancer Center
Guangzhou, China
Shanghai Pulmonary Hospital
Shanghai, China
Clinica CIMCA
San José, Costa Rica
Kasr Eieny Uni Hospital
Cairo, Egypt
Chu Grenoble - Hopital Albert Michallon
Grenoble, France
CHRU de Lille
Lille, France
Centre Leon Berard
Lyon, France
Hopital Haut Leveque
Pessac, France
Grupo Angeles
Guatemala City, Guatemala
Tuen Mun Hospital
Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Hong Kong, Hong Kong
Rambam Medical Center
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Irccs Ist. Tumori Giovanni Paolo Ii
Bari, Apulia, Italy
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy
Ospedale Provinciale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, Italy
Policlinico Umberto i di Roma
Rome, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima
Catania, Sicily, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, Italy
Instituto Nacional De Enfermedades Respiratorias
Mexico City, Mexico CITY (federal District), Mexico
Uni of Auckland
Auckland, New Zealand
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie
Warsaw, Poland
CHUC - Unidade de Pneumologia Oncológica
Coimbra, Portugal
IPO de Lisboa
Lisbon, Portugal
IPO do Porto
Porto, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
SPb City Clin Onc Dsp
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute named after N.N. Petrov
Saint Petersburg, Sankt-Peterburg, Russia
N.N.Burdenko Main Military Clinical Hospital
Moscow, Russia
Clinical Center of Serbia
Belgrade, Serbia
Institute for pulmonary diseases of Vojvodina
Kamenitz, Serbia
National University Hospital
Singapore, Singapore
National Cancer Centre
Singapore, Singapore
National Cancer Center
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital General Univ. de Alicante
Alicante, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Universitaetsspital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
CHUV
Lausanne, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung Univ Hosp
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
National Cancer Inst.
Bangkok, Thailand
Chiang Rai Prachanukroh Hospital
Chiang Rai, Thailand
Khonkaen Hospital
Khonkaen, Thailand
King Chulalongkorn Memorial Hospital
Patumwan, Thailand
Songklanagarind Hospital
Songkhla, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
Adana, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, Turkey (Türkiye)
Kyiv Regional Oncological Dispensary
Kyiv, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre
Lviv, Ukraine
Birmingham Heartlands Hospital
Birmingham, United Kingdom
University College London Hospital
London, United Kingdom
Guys & St Thomas Hospital
London, United Kingdom