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NCT02075840CompletedPhase 3

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

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
303 (actual)
First submitted
27 Feb 2014
Start date
19 Aug 2014
Primary completion date
9 Feb 2017
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT02075840
EU CT number
2023-506859-13-00
EudraCT number
2013-004133-33

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 303
  • From 19 Aug 2014 to the primary completion date, 9 Feb 2017
  • 86 sites in 29 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment

Other illness

  • Participants with a previous malignancy within the past 3 years
  • Any gastrointestinal (GI) disorder or liver disease
  • History of organ transplant
  • Co-administration of anti-cancer therapies other than those administered in this study
  • History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
  • 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

Lab values

  • Participants with baseline QTc greater than (\>) 470 milliseconds or symptomatic bradycardia
  • 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

Other

  • Pregnancy or lactation

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (86)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queen Elizabeth Hospital
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AdelaideAustraliaUnknown status
Kinghorn Cancer Centre
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DarlinghurstAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
Monash Health Translational Precinct
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VictoriaAustraliaUnknown status
Calvary Mater Newcastle
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WaratahAustraliaUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Saskatoon Cancer Centre
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SaskatoonCanadaUnknown status
Sunnybrook Odette Cancer Centre
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TorontoCanadaUnknown status
Mount Sinai Hospital
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TorontoCanadaUnknown status
Universitaetsspital Basel
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BaselSwitzerlandUnknown status
Inselspital Bern
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BernSwitzerlandUnknown status
CHUV
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LausanneSwitzerlandUnknown status
Universitätsspital Zürich
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ZurichSwitzerlandUnknown status
Centro Internacional de Estudios Clínicos (CIEC)
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SantiagoChileUnknown status
Sun Yet-Sen University Cancer Center
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GuangzhouChinaUnknown status
Shanghai Pulmonary Hospital
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ShanghaiChinaUnknown status
Clinica CIMCA
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San JoséCosta RicaUnknown status
Kasr Eieny Uni Hospital
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CairoEgyptUnknown status
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
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MajadahondaSpainCompleted
Chu Grenoble - Hopital Albert Michallon
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GrenobleFranceUnknown status
CHRU de Lille
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LilleFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Hopital Haut-Leveque
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PessacFranceUnknown status
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
Guys & St Thomas Hospital
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LondonUnited KingdomUnknown status
Grupo Angeles
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Guatemala CityGuatemalaUnknown status
Prince of Wales Hosp
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Hong KongHong Kong SAR ChinaUnknown status
Princess Margaret Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Pamela Youde Nethersole Eastern Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Tuen Mun Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Hospital Santa Maria Della Misericordia
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PerugiaItalyCompleted
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Gyeonggi-doSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Instituto Nacional de Enfermedades Respiratorias
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Mexico CityMexicoUnknown status
Uni of Auckland
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AucklandNew ZealandUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandCompleted
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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OtwockPolandCompleted
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalCompleted
Clinical Center of Serbia
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BelgradeSerbiaUnknown status
Institute for Pulmonary Diseases of Vojvodina
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KamenitzSerbiaUnknown status
Moscow City Oncology Hospital #62
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Moscovskaya OblastRussiaUnknown status
N.N.Burdenko Main Military Clinical Hospital
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MoscowRussiaUnknown status
Scientific Research Oncology Institute named after N.N. Petrov
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Saint PetersburgRussiaUnknown status
SPb City Clin Onc Dsp
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Saint PetersburgRussiaUnknown status
National University Hospital
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SingaporeSingaporeUnknown status
National Cancer Centre
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SingaporeSingaporeUnknown status
National Cancer Inst.
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BangkokThailandUnknown status
Chiang Rai Prachanukroh Hospital
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Chiang RaiThailandUnknown status
Khonkaen Hospital
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KhonkaenThailandUnknown status
King Chulalongkorn Memorial Hospital
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PatumwanThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Cheng Kung Univ Hosp
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Kyiv Regional Oncological Dispensary
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KyivUkraineUnknown status
Lviv State Oncology Regional Treatment and Diagnostic Centre
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LvivUkraineUnknown status
University of Colorado Cancer Center
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AuroraUnited StatesUnknown status
Dana Farber Can Ins
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BostonUnited StatesUnknown status
Beth Israel Deaconess Med Ctr
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BostonUnited StatesUnknown status
University of Miami-Deerfield Beach
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Deerfield BeachUnited StatesUnknown status
Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
University of Texas M.D. Anderson Cancer Center
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HoustonUnited StatesUnknown status
SCRI Oncology Partners
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NashvilleUnited StatesUnknown status
North Valley Hem Onc Med Grp
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NorthridgeUnited StatesUnknown status
TMPN/ Cancer Care Associates
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Redondo BeachUnited StatesUnknown status
Washington Uni School of Medicine
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St LouisUnited StatesUnknown status
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
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AdanaTurkey (Türkiye)Unknown status
Ankara University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
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EdirneTurkey (Türkiye)Unknown status
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
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MalatyaTurkey (Türkiye)Unknown status
University Clinical Center Sarajevo
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SarajevoBosnia and HerzegovinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.