Lung Cancer Clinical Trial

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
Life expectancy of at least 12 weeks
Eastern cooperative oncology group performance status (ECOG PS) of 0-2
Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
Adequate renal, and hematologic function
Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment
Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline)
Negative pregnancy test for all females of child bearing potential
Use of highly effective contraception as defined by the study protocol

Exclusion Criteria:

Participants with a previous malignancy within the past 3 years
Any gastrointestinal (GI) disorder or liver disease
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
History of organ transplant
Co-administration of anti-cancer therapies other than those administered in this study
Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia
Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
Pregnancy or lactation
Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

303

Study ID:

NCT02075840

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 117 Locations for this study

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Mayo Clinic Arizona
Phoenix Arizona, 85259, United States
North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
Northridge California, 91328, United States
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange California, 92868, United States
TMPN/ Cancer Care Associates
Redondo Beach California, 90277, United States
UCSF Helen Diller Family CCC
San Francisco California, 94158, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction Colorado, 81501, United States
Banner MD Anderson Cancer Center
Greeley Colorado, 85234, United States
University of Miami-Deerfield Beach
Deerfield Beach Florida, 33442, United States
Cancer Institute of Florida PA
Orlando Florida, 32804, United States
Memorial Health Care System
Pembroke Pines Florida, 33028, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta Georgia, 30060, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston Massachusetts, 02215, United States
Dana Farber Can Ins
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Washington Uni School of Medicine
Saint Louis Missouri, 63110, United States
Comprehensive Cancer Center - Peak
Las Vegas Nevada, 89128, United States
Columbia University Medical Center
New York New York, 10032, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville Tennessee, 37203, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Kinghorn Cancer Centre; St Vincents Hospital
Darlinghurst New South Wales, 2010, Australia
Royal North Shore Hospital; Oncology
St. Leonards New South Wales, 2065, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah New South Wales, 2298, Australia
Queen Elizabeth Hospital; Medical Oncology
Woodville South South Australia, 5011, Australia
Monash Health Translational Precinct; Clinical Trials Centre, Level 3
Victoria , 3168, Australia
University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases
Banja Luka , 78000, Bosnia and Herzegovina
University Clinical Center Sarajevo;Clinic for Pulmonary disease
Sarajevo , 71000, Bosnia and Herzegovina
University Clinical Center Sarajevo;Institute of oncology
Sarajevo , 71000, Bosnia and Herzegovina
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianopolis SC, 88034, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
Mount Sinai Hospital; Oncology
Toronto Ontario, M5G 1, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon Saskatchewan, S7N 4, Canada
Centro Internacional de Estudios Clínicos (CIEC)
Santiago , 84203, Chile
Sun Yet-sen University Cancer Center
Guangzhou City , 51066, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Clinica CIMCA
San José , 10103, Costa Rica
Kasr Eieny Uni Hospital; Oncology (Nemrock)
Cairo , 11555, Egypt
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble , 38043, France
CHRU de Lille
Lille , 59037, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Hopital Haut Leveque
Pessac , 33604, France
Hopital Pontchaillou
Rennes , 35033, France
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe , 76137, Germany
Klinik Löwenstein gGmbH Medizinische Klinik II
Löwenstein , 74245, Germany
Grupo Angeles
Guatemala City , 01015, Guatemala
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Princess Margaret Hospital; Oncology
Hong Kong , , Hong Kong
Queen Mary Hospital; Medicine & Respiratory
Hong Kong , , Hong Kong
Tuen Mun Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin , , Hong Kong
Rambam Medical Center; Oncology
Haifa , 31096, Israel
Meir Medical Center; Oncology
Kfar-Saba , 44281, Israel
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
Napoli Campania, 80131, Italy
A.O. Universitaria Di Parma; Oncologia Medica
Parma Emilia-Romagna, 43100, Italy
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
Ravenna Emilia-Romagna, 48100, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Roma Lazio, 00161, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano Lombardia, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano Lombardia, 20141, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano Piemonte, 10043, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari Puglia, 70124, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania Sicilia, 95122, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 003-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
Mexico City , 14080, Mexico
Uni of Auckland; Medical School
Auckland , , New Zealand
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk , 80-21, Poland
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
Lublin , 20-06, Poland
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock , 05-40, Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
Warszawa , 02-78, Poland
CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo
Coimbra , 3000-, Portugal
IPO de Lisboa; Servico de Pneumologia
Lisboa , 1099-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow , 10522, Russian Federation
City Clinical Hospital No. 1
Novosibirsk , 63004, Russian Federation
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
Obninsk , 24903, Russian Federation
SPb City Clin Onc Dsp; Chemotherapy
St. Petersburg , 19702, Russian Federation
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
St. Petersburg , 19775, Russian Federation
Clinical Center of Serbia
Belgrade , 11000, Serbia
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
National Cancer Centre; Medical Oncology
Singapore , 16961, Singapore
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda Madrid, 28222, Spain
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante , 3010, Spain
Hospital Universitario Quiron Dexeus
Barcelona , 08028, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Universitaetsspital Basel; Onkologie
Basel , 4031, Switzerland
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern , 3010, Switzerland
CHUV; Departement d'Oncologie
Lausanne , 1011, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland
National Cheng Kung Univ Hosp
Tainan , 00704, Taiwan
Taipei Veterans General Hospital
Taipei City , 112, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taichung Veterans General Hospital
Xitun Dist. , 40705, Taiwan
National Cancer Inst.
Bangkok , 10400, Thailand
Chiang Rai Prachanukroh Hospital; Department Of Medicine
Chiang Rai , 57000, Thailand
Khonkaen Hospital
Khonkaen , 40000, Thailand
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
Patumwan , 10330, Thailand
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Songkhla , 90110, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana , 01230, Turkey
Ankara University Medical Faculty; Medikal Onkoloji
Ankara , 06100, Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne , 22770, Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya , 44280, Turkey
Dnipropetrovsk State Medical Academy; Chemotherapy Department
Dnipropetrovsk , 49102, Ukraine
Karkiv Regional Oncology Center
Kharkiv , 61070, Ukraine
Kyiv Regional Oncological Dispensary
Kyiv , 04107, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
Lviv , 79031, Ukraine
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham , B9 5S, United Kingdom
University College London Hospital
London , N7 9N, United Kingdom
Guys & St Thomas Hospital; Department of Oncology
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

303

Study ID:

NCT02075840

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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