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

• ClinicalTrials.gov Identifier: NCT02075840
• Recruitment Status: Active, not recruiting
• First Posted: March 3, 2014
• Results First Posted: March 15, 2018
• Last Update Posted: October 10, 2019
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief 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, consent withdrawal or death. The study is expected to last approximately 42 months.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: Alectinib; Drug: Crizotinib	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 303 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 19, 2014
• Actual Primary Completion Date: February 9, 2017
• Estimated Study Completion Date: September 29, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Alectinib; Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.	Drug: 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.; Other Name: RO5424802
Active Comparator: Crizotinib; Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.	Drug: Crizotinib; Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival (PFS) by Investigator Assessment [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
2. Percentage of Participants With PFS Event by Investigator Assessment [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.

Secondary Outcome Measures :

1. PFS Independent Review Committee (IRC)-Assessed [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
2. Percentage of Participants With PFS Event by IRC [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
3. Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria [ Time Frame: Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) ]
   CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
4. Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria [ Time Frame: Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) ]
   CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
5. Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
6. Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators [ Time Frame: First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
7. Overall Survival (OS) [ Time Frame: From randomization until death (up to 43 months) ]
   Overall survival (OS) was defined as the time from randomization to death from any cause.
8. Percentage of Participants With OS Event [ Time Frame: From randomization until death (up to 43 months) ]
   Overall survival (OS) was defined as the time from randomization to death from any cause.
9. Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
   CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
10. CNS DOR IRC-assessed According to RECIST v1.1 Criteria [ Time Frame: First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
11. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm ]
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
12. Area Under The Concentration-Time Curve (AUC) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) ]
13. Maximum Concentration (Cmax) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
14. Time to Reach Cmax (Tmax) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
15. AUC of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) ]
16. Cmax of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
17. Tmax of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
18. Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
19. Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
20. Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
21. Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
22. Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
23. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
24. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
25. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
26. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

  Hide Study Locations

Locations

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85259

United States, California

St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

Fullerton, California, United States, 92835

Moores UCSD Cancer Center; Dept Clinical Trials Office

La Jolla, California, United States, 92093-0698

Long Beach Memorial Medical Center; Oncology

Long Beach, California, United States, 90806

North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr

Northridge, California, United States, 91328

Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

Orange, California, United States, 92868

TMPN/ Cancer Care Associates

Redondo Beach, California, United States, 90277

UCSF Helen Diller Family CCC

San Francisco, California, United States, 94158

United States, Colorado

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

St. Mary's Hospital Regional Cancer Center

Grand Junction, Colorado, United States, 81501

United States, Florida

University of Miami-Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Cancer Institute of Florida PA

Orlando, Florida, United States, 32804

Memorial Health Care System

Pembroke Pines, Florida, United States, 33028

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30308

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia, United States, 30060

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Med Ctr; Hem/Onc

Boston, Massachusetts, United States, 02215

Dana Farber Can Ins

Boston, Massachusetts, United States, 02215

United States, Michigan

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Henry Ford Health System

Detroit, Michigan, United States, 48202

United States, Missouri

Washington Uni School of Medicine

Saint Louis, Missouri, United States, 63110

United States, Nevada

Comprehensive Cancer Center - Peak

Las Vegas, Nevada, United States, 89128

United States, New York

Columbia University Medical Center

Bronx, New York, United States, 10463

United States, Pennsylvania

St. Lukes Hospital and Health Network

Bethlehem, Pennsylvania, United States, 18015

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States, 17033

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17604

University of Pittsburgh Medical Center; Division of Hematology-Oncology

Pittsburgh, Pennsylvania, United States, 15232

United States, Tennessee

Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

Nashville, Tennessee, United States, 37203

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390-8813

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Australia, New South Wales

Kinghorn Cancer Centre; St Vincents Hospital

Darlinghurst, New South Wales, Australia, 2010

Royal North Shore Hospital; Oncology

St. Leonards, New South Wales, Australia, 2065

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia, 2298

Australia, Queensland

Prince Charles Hospital

Chermside, Queensland, Australia, 4032

Australia, South Australia

Queen Elizabeth Hospital; Medical Oncology

Woodville South, South Australia, Australia, 5011

Australia

Monash Health Translational Precinct; Clinical Trials Centre, Level 3

Victoria, Australia, 3168

Bosnia and Herzegovina

University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases

Banja Luka, Bosnia and Herzegovina, 78000

University Clinical Center Sarajevo;Clinic for Pulmonary disease

Sarajevo, Bosnia and Herzegovina, 71000

University Clinical Center Sarajevo;Institute of oncology

Sarajevo, Bosnia and Herzegovina, 71000

Brazil

Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC

Fortaleza, CE, Brazil, 60125-120

Hospital das Clinicas - UFRGS

Porto Alegre, RS, Brazil, 90035-903

Centro de Pesquisas Oncologicas - CEPON

Florianopolis, SC, Brazil, 88034-000

Clinica de Neoplasias Litoral

Itajai, SC, Brazil, 88301-220

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, SP, Brazil, 01246-000

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, New Brunswick

Moncton Hospital

Moncton, New Brunswick, Canada, E1C 6Z8

Canada, Ontario

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Mount Sinai Hospital; Oncology

Toronto, Ontario, Canada, M5G 1X5

Canada, Saskatchewan

Saskatoon Cancer Centre; Uni of Saskatoon Campus

Saskatoon, Saskatchewan, Canada, S7N 4H4

Chile

Centro Internacional de Estudios Clínicos (CIEC)

Santiago, Chile, 8420383

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, Chile, 4810469

China

Sun Yet-sen University Cancer Center

Guangzhou, China, 510060

Shanghai Pulmonary Hospital

Shanghai, China, 200433

Costa Rica

Clinica CIMCA

San Jose, Costa Rica, 10103

Egypt

Kasr Eieny Uni Hospital; Oncology (Nemrock)

Cairo, Egypt, 11555

Nci; Oncology Dept

Cairo, Egypt, 11796

France

Centre Georges Francois Leclerc

Dijon, France, 21000

CHU de Grenoble

Grenoble, France, 38043

CHRU de Lille

Lille, France, 59037

Centre Leon Berard; Departement Oncologie Medicale

Lyon, France, 69373

Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

Marseille, France, 13915

Hopital Tenon;Pneumologie

Paris, France, 75970

Hopital Haut Leveque

Pessac, France, 33604

Hopital Pontchaillou

Rennes, France, 35033

Germany

St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

Karlsruhe, Germany, 76137

Klinik Löwenstein gGmbH Medizinische Klinik II

Löwenstein, Germany, 74245

Greece

Uoa Sotiria Hospital; Oncology

Athens, Greece, 115 27

Univ General Hosp Heraklion; Medical Oncology

Heraklion, Greece, 711 10

Guatemala

Grupo Angeles

Guatemala City, Guatemala, 01015

Hong Kong

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

Israel

Soroka Medical Center; Oncology Dept

Beer Sheva, Israel, 8410100

Rambam Medical Center; Oncology

Haifa, Israel, 3109601

Shaare Zedek Medical Center; Oncology Dept

Jerusalem, Israel, 91031

Meir Medical Center; Oncology

Kfar-Saba, Israel, 4428164

Belinson Medical Center, Division of Oncology

Petach Tikva, Israel, 4941492

Assaf Harofeh; Oncology

Zerifin, Israel, 6093000

Italy

Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology

Avellino, Campania, Italy, 83100

Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

Napoli, Campania, Italy, 80131

A.O. Universitaria Di Parma; Oncologia Medica

Parma, Emilia-Romagna, Italy, 43100

Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

Ravenna, Emilia-Romagna, Italy, 48100

Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

Roma, Lazio, Italy, 00161

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

Milano, Lombardia, Italy, 20133

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milano, Lombardia, Italy, 20141

Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

Orbassano, Piemonte, Italy, 10043

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Puglia, Italy, 70124

Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

Catania, Sicilia, Italy, 95122

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Perugia, Umbria, Italy, 06156

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

Padova, Veneto, Italy, 35128

Korea, Republic of

National Cancer Center

Gyeonggi-do, Korea, Republic of, 10408

Seoul National University Bundang Hospital

Gyeonggi-do, Korea, Republic of, 13620

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center - Oncology

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 6351

Mexico

Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación

Mexico City, Mexico, 14080

New Zealand

Uni of Auckland; Medical School

Auckland, New Zealand

Poland

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

Gdańsk, Poland, 80-214

Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, Poland, 20-064

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

Olsztyn, Poland, 10-357

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

Otwock, Poland, 05-400

Med.-Polonia Sp. z o.o. NSZOZ

Poznan, Poland, 60-693

Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

Warszawa, Poland, 02-781

Portugal

Hospital Geral; Servico de Pneumologia

Coimbra, Portugal, 3041-801

IPO de Lisboa; Servico de Pneumologia

Lisboa, Portugal, 1099-023

IPO do Porto; Servico de Oncologia Medica

Porto, Portugal, 4200-072

Russian Federation

N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

Moscow, Russian Federation, 105229

Moscow city oncology hospital #62 of Moscow Healthcare Department

Moscow, Russian Federation, 143423

City Clinical Hospital No. 1

Novosibirsk, Russian Federation, 630047

Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis

Obninsk, Russian Federation, 249036

SPb City Clin Onc Dsp; Chemotherapy

St. Petersburg, Russian Federation, 197022

Scientific Research Oncology Institute named after N.N. Petrov; Oncology

St. Petersburg, Russian Federation, 197758

Serbia

Clinical Center of Serbia

Belgrade, Serbia, 11000

Clinical Center Bezanijska Kosa; Oncology

Belgrade, Serbia, 11080

Institute for pulmonary diseases of Vojvodina

Sremska Kamenica, Serbia, 21204

Singapore

National University Hospital; National University Cancer Institute, Singapore (NCIS)

Singapore, Singapore, 119228

National Cancer Centre; Medical Oncology

Singapore, Singapore, 169610

Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, Spain, 08916

Hospital General Univ. de Alicante; Servicio de Oncologia

Alicante, Spain, 3010

Hospital Universitario Quiron Dexeus

Barcelona, Spain, 08028

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, Spain, 08035

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona, Spain, 08036

Hospital Universitario de la Princesa; Servicio de Oncologia

Madrid, Spain, 28006

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, Spain, 28034

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, Spain, 28041

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, Spain, 28046

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Madrid, Spain, 28222

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, Spain, 41013

Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

Zaragoza, Spain, 50009

Switzerland

Universitaetsspital Basel; Onkologie

Basel, Switzerland, 4031

Inselspital Bern; Universitätsklinik für medizinische Onkologie

Bern, Switzerland, 3010

CHUV; Departement d'Oncologie

Lausanne, Switzerland, 1011

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

Zürich, Switzerland, 8091

Taiwan

China Medical University Hospital

Taichung, Taiwan, 40447

Taichung Veterans General Hospital

Taichung, Taiwan, 407

National Cheng Kung Univ Hosp

Tainan, Taiwan, 00704

Taipei Veterans General Hospital

Taipei City, Taiwan, 112

National Taiwan University Hospital

Taipei, Taiwan, 10002

Chang Gung Memorial Hospital - Linkou

Taoyuan, Taiwan, 333

Thailand

National Cancer Inst.

Bangkok, Thailand, 10400

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

Bangkok, Thailand, 10700

Chiang Rai Prachanukroh Hospital; Department Of Medicine

Chiang Rai, Thailand, 57000

Khonkaen Hospital

Khonkaen, Thailand, 40000

King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University

Patumwan, Thailand, 10330

Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

Songkhla, Thailand, 90110

Turkey

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, Turkey, 01250

Ankara University Medical Faculty; Medikal Onkoloji

Ankara, Turkey, 06100

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Ankara, Turkey, 06100

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, Turkey, 22770

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, Turkey, 44280

Ukraine

Dnipropetrovsk State Medical Academy; Chemotherapy Department

Dnipropetrovsk, Ukraine, 49102

Karkiv Regional Oncology Center

Kharkiv, Ukraine, 61070

Kyiv Regional Oncological Dispensary

Kyiv, Ukraine, 04107

Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy

Lviv, Ukraine, 79031

United Kingdom

Birmingham Heartlands Hospital; Dept of Oncology

Birmingham, United Kingdom, B9 5SS

University College London Hospital

London, United Kingdom, NW1 - 2PG

Guys & St Thomas Hospital; Department of Oncology

London, United Kingdom, SE1 9RT

Royal Preston Hosp; Rosemere Cancer Ctr

Preston, United Kingdom, PR2 9HT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Statistical Analysis Plan  [PDF] February 6, 2018

Study Protocol  [PDF] February 6, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Pérol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nüesch E, Balas B, Camidge DR. Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study. Ann Oncol. 2018 Nov 1;29(11):2214-2222. doi: 10.1093/annonc/mdy405.

Burudpakdee C, Wong W, Seetasith A, Corvino FA, Yeh W, Gubens M. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9.

Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Pérol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.

Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02075840 History of Changes
• Other Study ID Numbers: BO28984; 2013-004133-33 ( EudraCT Number )
• First Posted: March 3, 2014
• Results First Posted: March 15, 2018
• Last Update Posted: October 10, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Crizotinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action