An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib (ReAlec)

A Multicenter Non-Interventional Cohort Study to Evaluate the Real-World Clinical Management and Outcomes of Patients Diagnosed With ALK-Positive Advanced NSCLC Treated With Alectinib (ReAlec)

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.

Study Overview

• Status: Active, not recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: Alectinib

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
    • Clinica Adventista Belgrano
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Lifehouse
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Genesiscare North Shore
    • St Leonards, New South Wales, Australia, 2065000
      • Royal North Shore Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Center
• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörtersee
  • Vienna, Austria, 1140
    • Klinik Penzing
  • Vienna, Austria, 1210
    • Krankenhaus Nord - Klinik Floridsdorf
• Belgium
  • Auderghem, Belgium, 1160
    • CHIREC
  • Ghent, Belgium, 9000
    • AZ Sint Lucas (Sint Lucas)
  • Hasselt, Belgium, 3500
    • Jessa Zkh (Campus Virga Jesse)
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Liège, Belgium, 4000
    • CHU de Liege
  • Ronse, Belgium, 9600
    • AZ Glorieux- vzw Werken Glorieux
  • Sint-Niklaas, Belgium, 9100
    • Vitaz
• Bulgaria
  • Burgas, Bulgaria
    • Complex Oncology Center Burgas
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment Uni Hospital
  • Plovdiv, Bulgaria, 4004
    • DDODIU-Plovdiv, EOOD
  • Sofia, Bulgaria, 1632
    • MBAL Serdika EOOD
  • Sofia, Bulgaria
    • Acibadem City Clinic Tokuda
• Chile
  • Santiago, Chile, 7500653
    • Centro de Estudios Clínicos SAGA
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7500691
      • Inst. Nacional Del Torax
• China
  • Changsha, China, 410006
    • Hu Nan Provincial Cancer Hospital
  • Guangzhou, China, 510060
    • Sun Yet-sen University Cancer Center
  • Guangzhou, China
    • Guangzhou Panyu Central Hospital
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Hefei, China
    • Anhui Chest Hospital
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Nanjing, China, 210036
    • Jiangsu Province Hospital
  • Nanning, China, 530021
    • Guangxi Cancer Hospital of Guangxi Medical University
  • Taiyuan, China, 030013
    • Shanxi Provincial Cancer hospital
  • Taizhou, China
    • Taizhou Hospital of Zhejiang Province
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300060
    • Tianjin cancer hospital
  • Wuhan, China, 430023
    • Union Hospital of Tongji Medical College, Dept. of Cancer Center
  • Xuzhou, China, 221004
    • The Affiliated Hospital of Xuzhou Medical College
• Colombia
  • Bogota, D.C., Colombia, 110131
    • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
  • Bogotá, Colombia, 000472
    • Hospital Universitario San Ignacio
  • Cali, Colombia, 760045
    • Angiografia del Occidente
  • Medellín, Colombia, 050024
    • Instituto Cancerología Medellin
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
• Cuba
  • La Habana, Cuba, 10300
    • Hospital Hermanos Ameijeiras
  • La Habana, Cuba, 10400
    • Instituto Nacional de Oncología y Radiología (INOR)
• Czechia
  • Brno, Czechia, 656 53
    • Masaryk?v onkologický ústav
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc
  • Praha 4 - Krc, Czechia, 140 59
    • Thomayerova nemocnice
• Finland
  • Tampere, Finland, 33520
    • Tampere University Hospital
  • Turku, Finland, 20521
    • Turku University Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Ichilov Sourasky Medical Center
• Italy
  • Apulia
    • Taranto, Apulia, Italy, 74121
      • Presidio Ospedaliero Centrale
  • Calabria
    • Reggio Calabria, Calabria, Italy, 89133
      • Grande Ospedale Metropolitano
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
  • Lazio
    • Rome, Lazio, Italy, 00133
      • Fondazione PTV Policlinico Tor Vergata
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"
    • Rome, Lazio, Italy, 00184
      • AZ. Ospedaliera San Giovanni - Addolorata
  • Liguria
    • Genoa, Liguria, Italy, 16149
      • A.O. Villa Scassi
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • ASST Spedali Civili di Brescia
    • Cremona, Lombardy, Italy, 26100
      • Asst Di Cremona
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • A.O.U. Maggiore della Carita
  • Sardinia
    • Cagliari, Sardinia, Italy, 09121
      • Ospedale Oncologico A.Businco
  • Sicily
    • Palermo, Sicily, Italy, 90146
      • AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello
  • Tuscany
    • Pistoia, Tuscany, Italy, 51100
      • Ospedale San Jacopo
    • Torrette, Tuscany, Italy, 60020
      • Clinica Oncologica-Ospedali Riuniti Ancona
  • Umbria
    • Perugia, Umbria, Italy, 06122
      • Ospedale Silvestrini
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Istituto Oncologico Veneto IRCCS
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
  • Vilnius, Lithuania, LT-08660
    • National Cancer Institute
• Panama
  • Panama City, Panama, 0816-04433
    • Instituto Oncológico Nacional (ION)
• Peru
  • Lima, Peru, Lima 34
    • Instituto Nacional de Enfermedades Neoplasicas
  • Lima, Peru, 41
    • Oncosalud Sac
  • Lima, Peru, 15036
    • Aliada Centro Oncologico
• Portugal
  • Porto, Portugal, 4200
    • Hospital de Sao Joao
  • Vila Nova de Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1
• Romania
  • Alba Iulia, Romania, 510077
    • Alba Emergency County Hospital
  • Bucharest, Romania, 050098
    • Emergency University Bucharest Hospital
  • Cluj-Napoca, Romania
    • Amethyst Cluj
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Iași, Romania, 700483
    • Institutul Regional de Oncologie Iasi
  • Ploieşti, Romania, 100337
    • Spitalul Municipal Ploiesti
  • Timișoara, Romania, 300239
    • Centrul de Oncologie Oncohelp
• Russia
  • Altayskiy Kray
    • Barnaul, Altayskiy Kray, Russia, 656049
      • Altai Regional Oncological Center
  • Bashkortostan Republic
    • Ufa, Bashkortostan Republic, Russia, 450054
      • Bashkirian Republican Clinical Oncology Dispensary
  • Krasnodarskiy Kray
    • Krasnoyarsk, Krasnodarskiy Kray, Russia, 660133
      • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
  • Moscow Oblast
    • Chelyabinsk, Moscow Oblast, Russia, 454087
      • Chelyabinsk Regional Clinical Oncology Dispensary
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 196006
      • Medical Clinic "AB Medical group"
• Serbia
  • Belgrade, Serbia, 11000
    • Clinic for Pulmonology, Clinical Center of Serbia
  • Belgrade, Serbia, 11080
    • University Hospital Medical Center Bezanijska kosa
  • Kamenitz, Serbia, 21204
    • Institute for Pulmonary Diseases of Vojvodina
  • Niš, Serbia, 18 000
    • Clinical Center Nis
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Adana Baskent University Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital
  • Ankara, Turkey (Türkiye), 06500
    • Gazi University Medical Faculty, Oncology Hospital
  • Ankara, Turkey (Türkiye), 06680
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06280
    • Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
  • Antalya, Turkey (Türkiye), 07100
    • Antalya Training And Research Hospital
  • Denizli, Turkey (Türkiye), 20070
    • Pamukkale University School Of Medicine
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34384
    • Prof. Dr. Cemil Tascioglu City Hospital
  • Istanbul, Turkey (Türkiye), 34000
    • Kartal Dr Lutfi Kirdar sehir Hastanesi
  • Izmir, Turkey (Türkiye), 35110
    • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Malatya, Turkey (Türkiye), 44280
    • Inonu University Medical Faculty of Medicine
  • Meram, Turkey (Türkiye), 42080
    • Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Mediclinic Airport Road Hospital
  • Dubai, United Arab Emirates, 31500
    • Mediclinic City Hospital
• Uruguay
  • Montevideo, Uruguay
    • Sanatorio CASMU
• Vietnam
  • Hanoi, Vietnam, 100000
    • K hospital
  • Hanoi, Vietnam, 100000
    • Hanoi Oncology Hospital
  • Hochiminh City, Vietnam, 700000
    • Hochiminh city oncology hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be identified in real-world clinical settings.

Description

Inclusion Criteria

• Confirmed diagnosis of advanced NSCLC (stage IIIB, IIIC, IVA, or IVB) on or after the date of local approval for alectinib as first-line treatment and/or second-line treatment for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study
• ALK-positive as confirmed by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), next generation sequencing (NGS), or other non-specified sequencing methods, documented prior to receiving treatment with an ALK inhibitor
• Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment
• Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment
• Able to be followed-up by participating site
• Participants with advanced NSCLC who have CNS metastases are eligible for inclusion

Exclusion Criteria

• Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information
• Participants not receiving the Roche studied medicinal product
• Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 2; Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.	Drug: Alectinib; Participants will receive alectinib in accordance with local clinical practice and local labeling.
Cohort 1; Participants starting alectinib treatment after (Arm A) or before (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years.	Drug: Alectinib; Participants will receive alectinib in accordance with local clinical practice and local labeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1	From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 4 years)
Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2	From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 2 years)
Choice of the Next Line of Treatment (LoT) Post-Alectinib	Up to approximately 1 year
Duration of Next LoT	Up to approximately 1 year
Reasons for Discontinuation of Next LoT	Up to approximately 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Loss of Clinical Benefit (TTLCB)	From the first administration of alectinib to loss of clinical benefit as assessed by the treating physician (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Overall Survival (OS)	From the first administration of alectinib to death from any cause (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR)	From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2)
Time to Response	From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Duration of Objective Response (DOR)	From first documentation of CR or PR (whichever occurs first) after the first administration of alectinib until death or progressive disease (PD) (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Disease Control Rate (DCR)	At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Duration of Disease Control	Time from the first administration of alectinib to the first documentation of CR, PR, or stable disease (whichever occurs first), until death or PD (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A)	Time interval from the first administration of alectinib to the date of confirmed CNS metastases in participants with no CNS metastases at baseline (up to 4 years)
Time to Initiation of Next Line of Treatment (LoT)	From the first administration of alectinib to the date of initiation of next LoT or death due to any cause, whichever occurs first (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores	At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2)	At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-LaRoche

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ALK-positive NSCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; alectinib
• Other Study ID Numbers: MO42122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing