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

NCT04764188 | Active Not Recruiting

• 1 other identifier: MO42122
• Study Type: observational
• Target: 800
• Locations: 24 countries
• Sites: 110

Brief 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.

Conditions

NSCLC

Keywords

ALK-positive NSCLC

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• 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)

Study Arms (2)

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

Cohort 2

Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.

Drug: Alectinib

Interventions

Alectinib DRUG

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

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (116)

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

Location

Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065000, Australia

Location

GenesisCare North Shore

St Leonards, New South Wales, 2065, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Peter MacCallum Cancer Center

East Melbourne, Victoria, 3002, Australia

Location

Klinikum Klagenfurt am Wörtersee

Klagenfurt, 9020, Austria

Location

Klinik Penzing

Vienna, 1140, Austria

Location

Krankenhaus Nord - Klinik Floridsdorf

Vienna, 1210, Austria

Location

CHIREC

Auderghem, 1160, Belgium

Location

AZ Sint Lucas (Sint Lucas)

Ghent, 9000, Belgium

Location

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

AZ Glorieux- vzw Werken Glorieux

Ronse, 9600, Belgium

Location

Vitaz

Sint-Niklaas, 9100, Belgium

Location

Complex Oncology Center Burgas

Burgas, Bulgaria

Location

Multiprofile Hospital for Active Treatment Uni Hospital

Panagyurishte, 4500, Bulgaria

Location

DDODIU-Plovdiv, EOOD

Plovdiv, 4004, Bulgaria

Location

MBAL Serdika EOOD

Sofia, 1632, Bulgaria

Location

Acibadem City Clinic Tokuda

Sofia, Bulgaria

Location

Inst. Nacional Del Torax

Santiago, Santiago Metropolitan, 7500691, Chile

Location

Centro de Estudios Clínicos SAGA

Santiago, 7500653, Chile

Location

Hu Nan Provincial Cancer Hospital

Changsha, 410006, China

Location

Sun Yet-sen University Cancer Center

Guangzhou, 510060, China

Location

Guangzhou Panyu Central Hospital

Guangzhou, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310009, China

Location

Anhui Chest Hospital

Hefei, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

Jiangsu Province Hospital

Nanjing, 210036, China

Location

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530021, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, 030013, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

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

Wuhan, 430023, China

Location

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, 221004, China

Location

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

Bogota, D.C., 110131, Colombia

Location

Hospital Universitario San Ignacio

Bogotá, 000472, Colombia

Location

Angiografia del Occidente

Cali, 760045, Colombia

Location

Instituto Cancerología Medellin

Medellín, 050024, Colombia

Location

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Hospital Hermanos Ameijeiras

La Habana, 10300, Cuba

Location

Instituto Nacional de Oncología y Radiología (INOR)

La Habana, 10400, Cuba

Location

Masaryk?v onkologický ústav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5262100, Israel

Location

Ichilov Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Presidio Ospedaliero Centrale

Taranto, Apulia, 74121, Italy

Location

Grande Ospedale Metropolitano

Reggio Calabria, Calabria, 89133, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione Ptv Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Policlinico Universitario "Agostino Gemelli"

Rome, Lazio, 00168, Italy

Location

AZ. Ospedaliera San Giovanni - Addolorata

Rome, Lazio, 00184, Italy

Location

A.O. Villa Scassi

Genoa, Liguria, 16149, Italy

Location

ASST Spedali Civili di Brescia

Brescia, Lombardy, 25123, Italy

Location

Asst Di Cremona

Cremona, Lombardy, 26100, Italy

Location

A.O.U. Maggiore della Carità

Novara, Piedmont, 28100, Italy

Location

Ospedale Oncologico A.Businco

Cagliari, Sardinia, 09121, Italy

Location

AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello

Palermo, Sicily, 90146, Italy

Location

Ospedale San Jacopo

Pistoia, Tuscany, 51100, Italy

Location

Clinica Oncologica-Ospedali Riuniti Ancona

Torrette, Tuscany, 60020, Italy

Location

Ospedale Silvestrini

Perugia, Umbria, 06122, Italy

Location

Istituto Oncologico Veneto IRCCS

Padova, Veneto, 35128, Italy

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

Kaunas, 50009, Lithuania

Location

National Cancer Institute

Vilnius, LT-08660, Lithuania

Location

Instituto Oncológico Nacional (ION)

Panama City, 0816-04433, Panama

Location

Aliada Centro Oncologico

Lima, 15036, Peru

Location

Oncosalud Sac

Lima, 41, Peru

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Hospital de Sao Joao

Porto, 4200, Portugal

Location

CHVNG/E_Unidade 1

Vila Nova de Gaia, 4434-502, Portugal

Location

Alba Emergency County Hospital

Alba Iulia, 510077, Romania

Location

Emergency University Bucharest Hospital

Bucharest, 050098, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Amethyst Cluj

Cluj-Napoca, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Spitalul Municipal Ploiesti

Ploieşti, 100337, Romania

Location

Centrul de Oncologie Oncohelp

Timișoara, 300239, Romania

Location

Altai Regional Oncological Center

Barnaul, Altayskiy Kray, 656049, Russia

Location

Bashkirian Republican Clinical Oncology Dispensary

Ufa, Bashkortostan Republic, 450054, Russia

Location

Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

Krasnoyarsk, Krasnodarskiy Kray, 660133, Russia

Location

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, Moscow Oblast, 454087, Russia

Location

Medical Clinic "AB Medical group"

Saint Petersburg, Sankt-Peterburg, 196006, Russia

Location

Clinic for Pulmonology, Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

University Hospital Medical Center Bezanijska kosa

Belgrade, 11080, Serbia

Location

Institute for pulmonary diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Nis

Niš, 18 000, Serbia

Location

Adana Baskent University Hospital

Adana, 01120, Turkey (Türkiye)

Location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi

Ankara, 06280, Turkey (Türkiye)

Location

Gazi University Medical Faculty, Oncology Hospital

Ankara, 06500, Turkey (Türkiye)

Location

Liv Hospital Ankara

Ankara, 06680, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Location

Pamukkale University School Of Medicine

Denizli, 20070, Turkey (Türkiye)

Location

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

Edirne, 22030, Turkey (Türkiye)

Location

Kartal Dr Lutfi Kirdar Sehir Hastanesi

Istanbul, 34000, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

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

Izmir, 35110, Turkey (Türkiye)

Location

Inonu University Medical Faculty of Medicine

Malatya, 44280, Turkey (Türkiye)

Location

Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre

Meram, 42080, Turkey (Türkiye)

Location

Mediclinic Airport Road Hospital

Abu Dhabi, United Arab Emirates

Location

Mediclinic City Hospital

Dubai, 31500, United Arab Emirates

Location

Sanatorio CASMU

Montevideo, Uruguay

Location

Hanoi Oncology Hospital

Hanoi, 100000, Vietnam

Location

K hospital

Hanoi, 100000, Vietnam

Location

Hochiminh city oncology hospital

Hochiminh City, 700000, Vietnam

Location

MeSH Terms

Interventions

alectinib

Study Officials

• Clinical Trials

  Hoffmann-LaRoche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 21, 2021
• Study Start: May 10, 2021
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CR (2); AE (2); SE (4); UR (1); LI (2); CU (2); IT (16); CO (4); RO (7); RU (5); PA (1); VN (3); FI (2); BU (5); AU (3); IL (4); BE (7); PE (3); CL (2); CN (14); AR (1); CZ (3); PT (2); TU (15)