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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alectinib
Crizotinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona
  • North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
  • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
  • TMPN/ Cancer Care Associates
  • UCSF Helen Diller Family CCC
  • University of Colorado Cancer Center
  • St. Mary's Hospital Regional Cancer Center
  • Banner MD Anderson Cancer Center
  • University of Miami-Deerfield Beach
  • Cancer Institute of Florida PA
  • Memorial Health Care System
  • Emory University Hospital
  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • University of Illinois at Chicago
  • Massachusetts General Hospital Cancer Center
  • Beth Israel Deaconess Med Ctr; Hem/Onc
  • Dana Farber Can Ins
  • Karmanos Cancer Institute
  • Henry Ford Health System
  • Washington Uni School of Medicine
  • Comprehensive Cancer Center - Peak
  • Columbia University Medical Center
  • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
  • UT Southwestern Medical Center
  • University of Texas M.D. Anderson Cancer Center
  • Kinghorn Cancer Centre; St Vincents Hospital
  • Royal North Shore Hospital; Oncology
  • Calvary Mater Newcastle; Medical Oncology
  • Queen Elizabeth Hospital; Medical Oncology
  • Monash Health Translational Precinct; Clinical Trials Centre, Level 3
  • University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases
  • University Clinical Center Sarajevo;Clinic for Pulmonary disease
  • University Clinical Center Sarajevo;Institute of oncology
  • Hospital das Clinicas - UFRGS
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Cross Cancer Institute
  • Sunnybrook Odette Cancer Centre
  • Mount Sinai Hospital; Oncology
  • Saskatoon Cancer Centre; Uni of Saskatoon Campus
  • Centro Internacional de Estudios Clínicos (CIEC)
  • Sun Yet-sen University Cancer Center
  • Shanghai Pulmonary Hospital
  • Clinica CIMCA
  • Kasr Eieny Uni Hospital; Oncology (Nemrock)
  • Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
  • CHRU de Lille
  • Centre Leon Berard; Departement Oncologie Medicale
  • Hopital Haut Leveque
  • Hopital Pontchaillou
  • St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
  • Klinik Löwenstein gGmbH Medizinische Klinik II
  • Grupo Angeles
  • Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
  • Princess Margaret Hospital; Oncology
  • Queen Mary Hospital; Medicine & Respiratory
  • Tuen Mun Hospital; Clinical Oncology
  • Prince of Wales Hosp; Dept. Of Clinical Onc
  • Rambam Medical Center; Oncology
  • Meir Medical Center; Oncology
  • Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
  • A.O. Universitaria Di Parma; Oncologia Medica
  • Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
  • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
  • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
  • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
  • Uni of Auckland; Medical School
  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
  • CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo
  • IPO de Lisboa; Servico de Pneumologia
  • IPO do Porto; Servico de Oncologia Medica
  • Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
  • Moscow City Oncology Hospital #62
  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
  • SPb City Clin Onc Dsp; Chemotherapy
  • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
  • City Clinical Hospital No. 1
  • Clinical Center of Serbia
  • Institute for pulmonary diseases of Vojvodina
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical Oncology
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Hospital General Univ. de Alicante; Servicio de Oncologia
  • Hospital Universitario Quiron Dexeus
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Universitaetsspital Basel; Onkologie
  • Inselspital Bern; Universitätsklinik für medizinische Onkologie
  • CHUV; Departement d'Oncologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • National Cheng Kung Univ Hosp
  • Taipei Veterans General Hospital
  • National Taiwan University Hospital
  • Taichung Veterans General Hospital
  • National Cancer Inst.
  • Chiang Rai Prachanukroh Hospital; Department Of Medicine
  • Khonkaen Hospital
  • King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
  • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Ankara University Medical Faculty; Medikal Onkoloji
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • Dnipropetrovsk State Medical Academy; Chemotherapy Department
  • Karkiv Regional Oncology Center
  • Kyiv Regional Oncological Dispensary
  • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
  • Birmingham Heartlands Hospital; Dept of Oncology
  • University College London Hospital
  • Guys & St Thomas Hospital; Department of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alectinib

Crizotinib

Arm Description

Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) by Investigator Assessment
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.
Percentage of Participants With PFS Event by Investigator Assessment
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

PFS Independent Review Committee (IRC)-Assessed
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.
Percentage of Participants With PFS Event by IRC
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.
Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria
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.
Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria
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.
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
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.
Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators
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.
Overall Survival (OS)
Overall survival (OS) was defined as the time from randomization to death from any cause.
Percentage of Participants With OS Event
Overall survival (OS) was defined as the time from randomization to death from any cause.
Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria
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.
CNS DOR IRC-assessed According to RECIST v1.1 Criteria
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.
Percentage of Participants With Adverse Events
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.
Area Under The Concentration-Time Curve (AUC) of Alectinib
Maximum Concentration (Cmax) of Alectinib
Time to Reach Cmax (Tmax) of Alectinib
AUC of Alectinib Metabolite
Cmax of Alectinib Metabolite
Tmax of Alectinib Metabolite
Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)
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.
Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
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.
Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
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.
Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
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.
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
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.
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing
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.
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea
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.
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest
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.
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder
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.

Full Information

First Posted
February 27, 2014
Last Updated
August 24, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02075840
Brief Title
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Acronym
ALEX
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2014 (Actual)
Primary Completion Date
February 9, 2017 (Actual)
Study Completion Date
September 29, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. 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, withdrawal of consent, or death. The study is expected to last approximately 144 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alectinib
Arm Type
Experimental
Arm Description
Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Arm Title
Crizotinib
Arm Type
Active Comparator
Arm Description
Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Intervention Type
Drug
Intervention Name(s)
Alectinib
Other Intervention Name(s)
RO5424802
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Intervention Description
Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) by Investigator Assessment
Description
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.
Time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Title
Percentage of Participants With PFS Event by Investigator Assessment
Description
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.
Time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary Outcome Measure Information:
Title
PFS Independent Review Committee (IRC)-Assessed
Description
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.
Time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Title
Percentage of Participants With PFS Event by IRC
Description
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.
Time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Title
Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria
Description
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.
Time Frame
Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)
Title
Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria
Description
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.
Time Frame
Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)
Title
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
Description
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.
Time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Title
Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators
Description
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.
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)
Title
Overall Survival (OS)
Description
Overall survival (OS) was defined as the time from randomization to death from any cause.
Time Frame
From randomization until death (up to 43 months)
Title
Percentage of Participants With OS Event
Description
Overall survival (OS) was defined as the time from randomization to death from any cause.
Time Frame
From randomization until death (up to 43 months)
Title
Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria
Description
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.
Time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Title
CNS DOR IRC-assessed According to RECIST v1.1 Criteria
Description
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.
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)
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
Title
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder
Description
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.
Time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
TMPN/ Cancer Care Associates
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
UCSF Helen Diller Family CCC
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
St. Mary's Hospital Regional Cancer Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
85234
Country
United States
Facility Name
University of Miami-Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Cancer Institute of Florida PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Memorial Health Care System
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr; Hem/Onc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Can Ins
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington Uni School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Comprehensive Cancer Center - Peak
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8813
Country
United States
Facility Name
University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kinghorn Cancer Centre; St Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal North Shore Hospital; Oncology
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle; Medical Oncology
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Queen Elizabeth Hospital; Medical Oncology
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Monash Health Translational Precinct; Clinical Trials Centre, Level 3
City
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Sarajevo;Clinic for Pulmonary disease
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Sarajevo;Institute of oncology
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital; Oncology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Saskatoon Cancer Centre; Uni of Saskatoon Campus
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centro Internacional de Estudios Clínicos (CIEC)
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
Kasr Eieny Uni Hospital; Oncology (Nemrock)
City
Cairo
ZIP/Postal Code
11555
Country
Egypt
Facility Name
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Klinik Löwenstein gGmbH Medizinische Klinik II
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Grupo Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital; Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital; Medicine & Respiratory
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Facility Name
Rambam Medical Center; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center; Oncology
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Di Parma; Oncologia Medica
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95122
Country
Italy
Facility Name
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
City
Sant'Andrea Delle Fratte (PG)
State/Province
Umbria
ZIP/Postal Code
06132
Country
Italy
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Uni of Auckland; Medical School
City
Auckland
Country
New Zealand
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
IPO de Lisboa; Servico de Pneumologia
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
City
Obninsk
State/Province
Kaluga
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
SPb City Clin Onc Dsp; Chemotherapy
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Clinical Hospital No. 1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for pulmonary diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Univ. de Alicante; Servicio de Oncologia
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Universitario Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Universitaetsspital Basel; Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern; Universitätsklinik für medizinische Onkologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
CHUV; Departement d'Oncologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
National Cheng Kung Univ Hosp
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Xitun Dist.
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cancer Inst.
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Chiang Rai Prachanukroh Hospital; Department Of Medicine
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Khonkaen Hospital
City
Khonkaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
City
Patumwan
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Ankara University Medical Faculty; Medikal Onkoloji
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Dnipropetrovsk State Medical Academy; Chemotherapy Department
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Karkiv Regional Oncology Center
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kyiv Regional Oncological Dispensary
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Birmingham Heartlands Hospital; Dept of Oncology
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
N7 9NH
Country
United Kingdom
Facility Name
Guys & St Thomas Hospital; Department of Oncology
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35275991
Citation
Dziadziuszko R, Peters S, Mok T, Camidge DR, Gadgeel SM, Ou SI, Konopa K, Noe J, Nowicka M, Bordogna W, Morcos PN, Smoljanovic V, Shaw AT. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. Clin Cancer Res. 2022 May 2;28(9):1800-1808. doi: 10.1158/1078-0432.CCR-21-2840.
Results Reference
derived
PubMed Identifier
32418886
Citation
Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Perol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanovic V, Hilton M, Ruf T, Noe J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11.
Results Reference
derived
PubMed Identifier
30215676
Citation
Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Perol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nuesch 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.
Results Reference
derived
PubMed Identifier
29656744
Citation
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.
Results Reference
derived
PubMed Identifier
28586279
Citation
Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol 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.
Results Reference
derived
PubMed Identifier
28501139
Citation
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. No abstract available.
Results Reference
derived

Learn more about this trial

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

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