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NSCLCReAlecNCT04764188

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

An observational study of NSCLC, run by Hoffmann-La Roche at 116 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
Alectinib
How many people
800 participants
Where
116 sitesin 25 countries
Study dates
10 May 2021to 10 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

116 sites in 25 countries.

116 sites in 25 countries

Italy16 sites

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • Ospedale Oncologico A.Businco

    Cagliari, Sardinia, 09121

  • Asst Di Cremona

    Cremona, Lombardy, 26100

  • A.O. Villa Scassi

    Genoa, Liguria, 16149

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello

    Palermo, Sicily, 90146

  • Ospedale Silvestrini

    Perugia, Umbria, 06122

  • Ospedale San Jacopo

    Pistoia, Tuscany, 51100

  • Grande Ospedale Metropolitano

    Reggio Calabria, Calabria, 89133

  • Fondazione Ptv Policlinico Tor Vergata

    Rome, Lazio, 00133

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168

  • AZ. Ospedaliera San Giovanni - Addolorata

    Rome, Lazio, 00184

  • Presidio Ospedaliero Centrale

    Taranto, Apulia, 74121

  • Clinica Oncologica-Ospedali Riuniti Ancona

    Torrette, Tuscany, 60020

Other trials in Italy

Turkey (Türkiye)15 sites

  • Adana Baskent University Hospital

    Adana, 01120

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi

    Ankara, 06280

  • Gazi University Medical Faculty, Oncology Hospital

    Ankara, 06500

  • Liv Hospital Ankara

    Ankara, 06680

  • Ankara City Hospital

    Ankara, 06800

  • Antalya Training and Research Hospital

    Antalya, 07100

  • Pamukkale University School Of Medicine

    Denizli, 20070

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi

    Istanbul, 34000

  • Medipol University Medical Faculty

    Istanbul, 34214

  • Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul, 34384

  • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

    Izmir, 35110

  • Inonu University Medical Faculty of Medicine

    Malatya, 44280

  • Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre

    Meram, 42080

Other trials in Turkey (Türkiye)

China14 sites

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Guangzhou Panyu Central Hospital

    Guangzhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

  • Anhui Chest Hospital

    Hefei

  • Shandong Cancer Hospital

    Jinan, 250117

  • Jiangsu Province Hospital

    Nanjing, 210036

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Tianjin Medical University General Hospital

    Tianjin

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center

    Wuhan, 430023

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221004

Other trials in China

Belgium7 sites

  • CHIREC

    Auderghem, 1160

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • CHU de Liège

    Liège, 4000

  • AZ Glorieux- vzw Werken Glorieux

    Ronse, 9600

  • Vitaz

    Sint-Niklaas, 9100

Other trials in Belgium

Romania7 sites

  • Alba Emergency County Hospital

    Alba Iulia, 510077

  • Emergency University Bucharest Hospital

    Bucharest, 050098

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Amethyst Cluj

    Cluj-Napoca

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

  • Centrul de Oncologie Oncohelp

    Timișoara, 300239

Other trials in Romania

Australia6 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Lifehouse

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Center

    East Melbourne, Victoria, 3002

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065000

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065

Other trials in Australia

Bulgaria5 sites

  • Complex Oncology Center Burgas

    Burgas

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500

  • DDODIU-Plovdiv, EOOD

    Plovdiv, 4004

  • MBAL Serdika EOOD

    Sofia, 1632

  • Acibadem City Clinic Tokuda

    Sofia

Other trials in Bulgaria

Russia5 sites

  • Altai Regional Oncological Center

    Barnaul, Altayskiy Kray, 656049

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, Moscow Oblast, 454087

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

    Krasnoyarsk, Krasnodarskiy Kray, 660133

  • Medical Clinic "AB Medical group"

    Saint Petersburg, Sankt-Peterburg, 196006

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, Bashkortostan Republic, 450054

Other trials in Russia

Colombia4 sites

  • Hospital Universitario San Ignacio

    Bogotá, 000472

  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    Bogota, D.C., 110131

  • Angiografia del Occidente

    Cali, 760045

  • Instituto Cancerología Medellin

    Medellín, 050024

Other trials in Colombia

Israel4 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Ichilov Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Serbia4 sites

  • Clinic for Pulmonology, Clinical Center of Serbia

    Belgrade, 11000

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080

  • Institute for pulmonary diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Center Nis

    Niš, 18 000

Other trials in Serbia

Austria3 sites

  • Klinikum Klagenfurt am Wörtersee

    Klagenfurt, 9020

  • Klinik Penzing

    Vienna, 1140

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210

Other trials in Austria

Czechia3 sites

  • Masaryk?v onkologický ústav

    Brno, 656 53

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Peru3 sites

  • Aliada Centro Oncologico

    Lima, 15036

  • Oncosalud Sac

    Lima, 41

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

Other trials in Peru

Vietnam3 sites

  • Hanoi Oncology Hospital

    Hanoi, 100000

  • K hospital

    Hanoi, 100000

  • Hochiminh city oncology hospital

    Hochiminh City, 700000

Other trials in Vietnam

Chile2 sites

  • Inst. Nacional Del Torax

    Santiago, Santiago Metropolitan, 7500691

  • Centro de Estudios Clínicos SAGA

    Santiago, 7500653

Other trials in Chile

Croatia2 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Cuba2 sites

  • Hospital Hermanos Ameijeiras

    La Habana, 10300

  • Instituto Nacional de Oncología y Radiología (INOR)

    La Habana, 10400

Other trials in Cuba

Finland2 sites

  • Tampere University Hospital

    Tampere, 33520

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

    Kaunas, 50009

  • National Cancer Institute

    Vilnius, LT-08660

Other trials in Lithuania

Portugal2 sites

  • Hospital de Sao Joao

    Porto, 4200

  • CHVNG/E_Unidade 1

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

United Arab Emirates2 sites

  • Mediclinic Airport Road Hospital

    Abu Dhabi

  • Mediclinic City Hospital

    Dubai, 31500

Other trials in United Arab Emirates

Argentina1 site

  • Clinica Adventista Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF

Other trials in Argentina

Panama1 site

  • Instituto Oncológico Nacional (ION)

    Panama City, 0816-04433

Other trials in Panama

Uruguay1 site

  • Sanatorio CASMU

    Montevideo

Other trials in Uruguay

About this study

Official title: 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.

Conditions
NSCLC
Being tested
Alectinib
Keywords
ALK-positive NSCLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlectinibDrug

    Participants will receive alectinib in accordance with local clinical practice and local labeling.

Study groups in NCT04764188
Study groupRoleWhat they receive
Cohort 1Participants 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.
Receives: Drug: Alectinib
Cohort 2Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
Receives: Drug: Alectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1

    Measured: 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)

  2. Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2

    Measured: 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)

  3. Choice of the Next Line of Treatment (LoT) Post-Alectinib

    Measured: Up to approximately 1 year

  4. Duration of Next LoT

    Measured: Up to approximately 1 year

  5. Reasons for Discontinuation of Next LoT

    Measured: Up to approximately 1 year

Secondary outcomes (11)

  1. Time to Loss of Clinical Benefit (TTLCB)

    Measured: 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)

  2. Overall Survival (OS)

    Measured: From the first administration of alectinib to death from any cause (up to 4 years for Cohort 1 and 2 years for Cohort 2)

  3. Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR)

    Measured: From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2)

  4. Time to Response

    Measured: From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and 2 years for Cohort 2)

  5. Duration of Objective Response (DOR)

    Measured: 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)

  6. Disease Control Rate (DCR)

    Measured: At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2)

  7. Duration of Disease Control

    Measured: 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)

  8. Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A)

    Measured: 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)

  9. Time to Initiation of Next Line of Treatment (LoT)

    Measured: 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)

  10. Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores

    Measured: At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)

  11. Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2)

    Measured: At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start10 May 2021
  3. Primary completion10 May 2027 (estimated)
  4. Study completion10 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764188
Sponsor's protocol ID
MO42122
Acronym
ReAlec
Status last verified
Oct 2026
First submitted
5 Feb 2021
Last updated
8 Oct 2026
Results posted
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC, run by Hoffmann-La Roche at 116 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Italy, Turkey (Türkiye), China, Belgium, Romania and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1 (time frame: 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04764188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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