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

May 28, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Kinghorn Cancer Centre
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • South Australia
      • Adelaide, South Australia, Australia, 5011
        • Queen Elizabeth Hospital
    • Victoria
      • Victoria, Victoria, Australia, 3168
        • Monash Health Translational Precinct
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • University Clinical Center Sarajevo
  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Câncer do Estado de São Paulo - ICESP
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Chile
      • Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos (CIEC)
  • China
      • Guangzhou, China, 510060
        • Sun Yet-sen University Cancer Center
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
  • Costa Rica
      • San José, Costa Rica, DUMMY_VALUE
        • Clinica CIMCA
  • Egypt
      • Cairo, Egypt, 11555
        • Kasr Eieny Uni Hospital
  • France
      • Grenoble, France, 38043
        • Chu Grenoble - Hopital Albert Michallon
      • Lille, France, 59037
        • CHRU de Lille
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Pessac, France, 33604
        • Hôpital Haut Lévêque
  • Guatemala
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong, DUMMY_VALUE
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hosp
      • Hong Kong, Hong Kong, DUMMY_VALUE
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong, DUMMY_VALUE
        • Queen Mary Hospital
  • Israel
      • Haifa, Israel, 4959381
        • Rambam Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
  • Italy
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Irccs Ist. Tumori Giovanni Paolo Ii
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43100
        • A.O. Universitaria Di Parma
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Ospedale Provinciale Santa Maria Delle Croci
    • Lazio
      • Rome, Lazio, Italy, 00161
        • Policlinico Umberto i di Roma
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Milan, Lombardy, Italy, 20141
        • Irccs Istituto Europeo di Oncologia (IEO)
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
    • Sicily
      • Catania, Sicily, Italy, 95122
        • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
  • Mexico
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias
  • New Zealand
      • Auckland, New Zealand, DUMMY_VALUE
        • Uni of Auckland
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Lublin, Poland, 20-064
        • Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
      • Olsztyn, Poland, 10-357
        • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
      • Warsaw, Poland, 02-781
        • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie
  • Portugal
      • Coimbra, Portugal, 3000-075
        • CHUC - Unidade de Pneumologia Oncológica
      • Lisbon, Portugal, 1099-023
        • IPO de Lisboa
      • Porto, Portugal, 4200-072
        • IPO do Porto
  • Russia
      • Moscow, Russia, 105229
        • N.N.Burdenko Main Military Clinical Hospital
    • Moscow Oblast
      • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
        • Moscow City Oncology Hospital #62
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197022
        • SPb City Clin Onc Dsp
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • Scientific Research Oncology Institute named after N.N. Petrov
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Kamenitz, Serbia, 21204
        • Institute for Pulmonary Diseases of Vojvodina
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Singapore, 119228
        • National University Hospital
  • South Korea
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Alicante, Spain, 3010
        • Hospital General Univ. de Alicante
      • Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitaetsspital Basel
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Lausanne, Switzerland, 1011
        • CHUV
      • Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 00704
        • National Cheng Kung Univ Hosp
      • Taipei, Taiwan, 00100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 00112
        • Taipei Veterans General Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • National Cancer Inst.
      • Chiang Rai, Thailand, 57000
        • Chiang Rai Prachanukroh Hospital
      • Khonkaen, Thailand, 40000
        • Khonkaen Hospital
      • Patumwan, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Ankara University Medical Faculty
      • Edirne, Turkey (Türkiye), 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • Ukraine
      • Kyiv, Ukraine, 04107
        • Kyiv Regional Oncological Dispensary
      • Lviv, Ukraine, 79031
        • Lviv State Oncology Regional Treatment and Diagnostic Centre
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • London, United Kingdom, NW1 - 2PG
        • University College London Hospital
      • London, United Kingdom, SE1 9RT
        • Guys & St Thomas Hospital
  • United States
    • California
      • Northridge, California, United States, 91325
        • North Valley Hem Onc Med Grp
      • Redondo Beach, California, United States, 90277
        • TMPN/ Cancer Care Associates
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami-Deerfield Beach
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Can Ins
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington Uni School of Medicine
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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.
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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.
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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.
Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)
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.
Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)
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.
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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.
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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.
First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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.
Baseline, every 4 weeks until disease progression (up to 33 months)
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 approximately 10 years)
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.
First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to approximately 10 years)
Overall Survival (OS)
Time Frame: From randomization until death (up to 10.5 years)
Overall survival (OS) was defined as the time from randomization to death from any cause.
From randomization until death (up to 10.5 years)
Percentage of Participants With OS Event
Time Frame: From randomization until death (up to 10.5 years)
Overall survival (OS) was defined as the time from randomization to death from any cause.
From randomization until death (up to 10.5 years)
Percentage of Participants With Adverse Events
Time Frame: Baseline up to approximately 10 years
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.
Baseline up to approximately 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO28984
  • 2013-004133-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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