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

NSCLC Clinical Trial

— ReAlec  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04764188
• Other study ID #: MO42122
• Status: Active, not recruiting
• Start date: May 10, 2021
• Est. completion date: May 10, 2027

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: May 10, 2027
• Est. primary completion date: May 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.

Locations

Country	Name	City	State
Argentina	Clinica Adventista Belgrano; Oncology	Ciudad Autonoma Buenos Aires
Australia	Flinders Medical Centre; Medical Oncology	Bedford Park	South Australia
Australia	Lifehouse	Camperdown	New South Wales
Australia	Liverpool Hospital; Cancer Therapy Centre	Liverpool	New South Wales
Australia	Peter MacCallum Cancer Center	North Melbourne	Victoria
Australia	Northern Cancer Institute	St Leonards	New South Wales
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Austria	Klinikum Klagenfurt am Wörtersee	Klagenfurt am Worthersee
Austria	Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten	Wien
Austria	Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie	Wien
Belgium	CHIREC	Auderghem
Belgium	AZ Sint Lucas (Sint Lucas)	Gent
Belgium	Jessa Zkh (Campus Virga Jesse)	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	CHU de Liège	Liège
Belgium	AZ Glorieux- vzw Werken Glorieux	Ronse
Belgium	Vitaz	Sint Niklaas
Bulgaria	Complex Oncology Center Burgas; Department of medical oncology	Burgas
Bulgaria	Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology	Panagyurishte
Bulgaria	Complex Oncology Center - Plovdiv First Internal Chemotherapy Department	Plovdiv
Bulgaria	Acibadem City Clinic Tokuda; Department of medical oncology	Sofia
Bulgaria	MBAL Serdika EOOD	Sofia
Chile	Centro de Estudios Clínicos SAGA	Santiago
Chile	Inst. Nacional Del Torax; Pulmonology	Santiago
China	Hu Nan Provincial Cancer Hospital	Changsha
China	Guangzhou Panyu Central Hospital	Guangzhou
China	Sun Yet-sen University Cancer Center	Guangzhou City
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou City
China	Anhui Chest Hospital	Hefei
China	Shandong Cancer Hospital	Jinan
China	Jiangsu Province Hospital	Nanjing
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning City
China	Shanxi Provincial Cancer Hospital	Taiyuan
China	Taizhou Hospital of Zhejiang Province	Taizhou
China	Tianjin Cancer Hospital	Tianjin
China	Tianjin Medical University General Hospital; Lung Cancer Surgery Department	Tianjin
China	Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center	Wuhan
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou
China	Henan Provincial People's Hospital	Zhengzhou
Colombia	Hospital Universitario San Ignacio	Bogota
Colombia	Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo	Bogota, D.C.
Colombia	Angiografia del Occidente	Cali
Colombia	Instituto Cancerologia Medellin; Clinica Las Americas	Medellin
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Cuba	Hospital Hermanos Ameijeiras	La Habana
Cuba	Instituto Nacional de Oncología y Radiología (INOR)	La Habana
Czechia	Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e	Brno
Czechia	Fakultni nemocnice Olomouc; Pneumologicka klinika	Olomouc
Czechia	Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN	Praha 4 - Krc
Finland	Tampere University Hospital; Dept of Oncology	Tampere
Finland	Turku University Hospital	Turku
Israel	Rambam Health Care Campus; Oncology	Haifa
Israel	Rabin Medical Center; Oncology Dept	Petah Tikva
Israel	Chaim Sheba Medical Center; Oncology Dept	Ramat Gan
Israel	Ichilov Sourasky Medical Center; Heamatology	Tel Aviv
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	Ospedale Oncologico A.Businco; Div. Oncologia Medica II	Cagliari	Sardegna
Italy	Ospedale Clinicizzato SS Annunziata	Chieti	Abruzzo
Italy	ASST DI CREMONA; Dip. Medicina - S.C. Oncologia	Cremona	Lombardia
Italy	A.O. Villa Scassi; Oncologia Medica	Genova	Liguria
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	A.O.U. Maggiore della Carità	Novara	Piemonte
Italy	Istituto Oncologico Veneto IRCCS	Padova	Veneto
Italy	AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello; Dip. Ematologia e Oncologia	Palermo	Sicilia
Italy	Ospedale Silvestrini	Perugia	Umbria
Italy	Ospedale San Jacopo; Dipartimento Oncologico	Pistoia	Toscana
Italy	Grande Ospedale Metropolitano; Oncologia Medica	Reggio Calabria	Calabria
Italy	AZ. Ospedaliera San Giovanni - Addolorata	Roma	Lazio
Italy	Fondazione Ptv Policlinico Tor Vergata	Roma	Lazio
Italy	Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica	Roma	Lazio
Italy	Presidio Ospedaliero Centrale; Ospedale S.S. Annunziata	Taranto	Puglia
Italy	Clinica Oncologica-Ospedali Riuniti Ancona	Torrette	Toscana
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution	Kaunas
Lithuania	National Cancer Institute; Department of Thoracic Surgery and Oncology	Vilnius
Panama	Instituto Oncológico Nacional (ION)	Panama City
Peru	Aliada Centro Oncologico	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Oncosalud Sac; Oncología	Lima
Portugal	Hospital de Sao Joao; Servico de Pneumologia	Porto
Portugal	CHVNG/E_Unidade 1; Servico de Pneumologia	Vila Nova de Gaia
Romania	Alba Emergency County Hospital	Alba Iulia
Romania	Emergency University Bucharest Hospital; Oncology Department	Bucharest
Romania	Amethyst Cluj	Cluj-Napoca
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie	Cluj-Napoca
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Spitalul Municipal Ploiesti	Ploiesti
Romania	Centrul de Oncologie Oncohelp	Timisoara
Russian Federation	ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic	Barnaul	Altaj
Russian Federation	Chelyabinsk Regional Clinical Oncology Dispensary	Chelyabinsk	Moskovskaja Oblast
Russian Federation	Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy	Krasnoyarsk	Krasnodar
Russian Federation	LLC "Oncology scientific centre"	Pesochny	Sankt Petersburg
Russian Federation	Bashkirian Republican Clinical Oncology Dispensary	UFA	Baskortostan
Serbia	Clinic for Pulmonology, Clinical Center of Serbia	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Serbia	Clinical Center Nis; Clinic for pulmonary diseases	Nis
Serbia	Institute for pulmonary diseases of Vojvodina	Sremska Kamenica
Turkey	Adana Baskent University Hospital; Medical Oncology	Adana
Turkey	Ankara City Hospital; Oncology	Ankara
Turkey	Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi; Medical Oncology	Ankara
Turkey	Gazi University Medical Faculty, Oncology Hospital	Ankara
Turkey	Gulhane Training and Research Hospital	Ankara
Turkey	Liv Hospital Ankara; Medical Oncology	Ankara
Turkey	Antalya Training and Research Hospital ; Oncology Department	Antalya
Turkey	Pamukkale University School Of Medicine; Oncology Department	Denizli
Turkey	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne
Turkey	Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department	Istanbul
Turkey	Medipol University Medical Faculty; Oncology Department	Istanbul
Turkey	Prof. Dr. Cemil Tascioglu City Hospital; Med Onc	Istanbul
Turkey	Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi	Izmir
Turkey	Inonu University Medical Faculty of Medicine; Medical Oncology Department	Malatya
Turkey	Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre	Meram
United Arab Emirates	Mediclinic Airport Road Hospital	Abu Dhabi
United Arab Emirates	Mediclinic City Hospital	Dubai
Uruguay	Sanatorio CASMU; Oncología	Montevideo
Vietnam	Hanoi Oncology Hospital	Hanoi
Vietnam	K hospital	Hanoi
Vietnam	Hochiminh city oncology hospital	Hochiminh city

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Chile,  China,  Colombia,  Croatia,  Cuba,  Czechia,  Finland,  Israel,  Italy,  Lithuania,  Panama,  Peru,  Portugal,  Romania,  Russian Federation,  Serbia,  Turkey,  United Arab Emirates,  Uruguay,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Choice of the Next Line of Treatment (LoT) Post-Alectinib		Up to approximately 1 year
Primary	Duration of Next LoT		Up to approximately 1 year
Primary	Reasons for Discontinuation of Next LoT		Up to approximately 1 year
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)