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
Sites (86)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Kinghorn Cancer Centre Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Monash Health Translational Precinct Coordinator of this site? Confirm its status | Victoria | Australia | Unknown status |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Saskatoon Cancer Centre Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Sunnybrook Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitaetsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Centro Internacional de Estudios Clínicos (CIEC) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Sun Yet-Sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Clinica CIMCA Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| Kasr Eieny Uni Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
| Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Chu Grenoble - Hopital Albert Michallon Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CHRU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guys & St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Grupo Angeles Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Prince of Wales Hosp Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Pamela Youde Nethersole Eastern Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Tuen Mun Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| National Cancer Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Instituto Nacional de Enfermedades Respiratorias Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Uni of Auckland Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Coordinator of this site? Confirm its status | Otwock | Poland | Completed |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Institute for Pulmonary Diseases of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| Moscow City Oncology Hospital #62 Coordinator of this site? Confirm its status | Moscovskaya Oblast | Russia | Unknown status |
| N.N.Burdenko Main Military Clinical Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Scientific Research Oncology Institute named after N.N. Petrov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| SPb City Clin Onc Dsp Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National Cancer Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National Cancer Inst. Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chiang Rai Prachanukroh Hospital Coordinator of this site? Confirm its status | Chiang Rai | Thailand | Unknown status |
| Khonkaen Hospital Coordinator of this site? Confirm its status | Khonkaen | Thailand | Unknown status |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Patumwan | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung Univ Hosp Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Kyiv Regional Oncological Dispensary Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Lviv State Oncology Regional Treatment and Diagnostic Centre Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| University of Colorado Cancer Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dana Farber Can Ins Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Med Ctr Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Miami-Deerfield Beach Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Texas M.D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| North Valley Hem Onc Med Grp Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| TMPN/ Cancer Care Associates Coordinator of this site? Confirm its status | Redondo Beach | United States | Unknown status |
| Washington Uni School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Ankara University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department Coordinator of this site? Confirm its status | Malatya | Turkey (Türkiye) | Unknown status |
| University Clinical Center Sarajevo Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.