Clinical trial NCT04764188: An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: NSCLC
Keywords: ALK-positive NSCLC
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be identified in real-world clinical settings.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1
timeFrame: 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)
measure: Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2
timeFrame: 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)
measure: Choice of the Next Line of Treatment (LoT) Post-Alectinib
timeFrame: Up to approximately 1 year
measure: Duration of Next LoT
timeFrame: Up to approximately 1 year
measure: Reasons for Discontinuation of Next LoT
timeFrame: Up to approximately 1 year
Secondary outcomes:
measure: Time to Loss of Clinical Benefit (TTLCB)
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: From the first administration of alectinib to death from any cause (up to 4 years for Cohort 1 and 2 years for Cohort 2)
measure: Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR)
timeFrame: From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2)
measure: Time to Response
timeFrame: From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and 2 years for Cohort 2)
measure: Duration of Objective Response (DOR)
timeFrame: 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)
measure: Disease Control Rate (DCR)
timeFrame: At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2)
measure: Duration of Disease Control
timeFrame: 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)
measure: Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A)
timeFrame: 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)
measure: Time to Initiation of Next Line of Treatment (LoT)
timeFrame: 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)
measure: Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
timeFrame: At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
measure: Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2)
timeFrame: At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Other outcomes:
Locations:
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Camperdown
country: Australia
facility: Lifehouse
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
city: Klagenfurt am Worthersee
country: Austria
facility: Klinikum Klagenfurt am Wörtersee
city: Wien
country: Austria
facility: Klinik Penzing
city: Wien
country: Austria
facility: Krankenhaus Nord - Klinik Floridsdorf
city: Auderghem
country: Belgium
facility: CHIREC
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU de Liège
city: Ronse
country: Belgium
facility: AZ Glorieux- vzw Werken Glorieux
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Burgas
country: Bulgaria
facility: Complex Oncology Center Burgas
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Uni Hospital
city: Plovdiv
country: Bulgaria
facility: DDODIU-Plovdiv, EOOD
city: Sofia
country: Bulgaria
facility: MBAL Serdika EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA
city: Santiago
country: Chile
facility: Inst. Nacional Del Torax
city: Changsha
country: China
facility: Hu Nan Provincial Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
city: Hangzhou City
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hefei
country: China
facility: Anhui Chest Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
city: Bogota, D.C.
country: Colombia
facility: Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Cali
country: Colombia
facility: Angiografia del Occidente
city: Medellin
country: Colombia
facility: Instituto Cancerología Medellin
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: La Habana
country: Cuba
facility: Hospital Hermanos Ameijeiras
city: La Habana
country: Cuba
facility: Instituto Nacional de Oncología y Radiología (INOR)
city: Brno
country: Czechia
facility: Masaryk?v onkologický ústav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Ichilov Sourasky Medical Center
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano
state: Calabria
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Ptv Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario "Agostino Gemelli"
state: Lazio
city: Roma
country: Italy
facility: AZ. Ospedaliera San Giovanni - Addolorata
state: Lazio
city: Genova
country: Italy
facility: A.O. Villa Scassi
state: Liguria
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: Lombardia
city: Cremona
country: Italy
facility: Asst Di Cremona
state: Lombardia
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Taranto
country: Italy
facility: Presidio Ospedaliero Centrale
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A.Businco
state: Sardegna
city: Palermo
country: Italy
facility: AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello
state: Sicilia
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
state: Toscana
city: Torrette
country: Italy
facility: Clinica Oncologica-Ospedali Riuniti Ancona
state: Toscana
city: Perugia
country: Italy
facility: Ospedale Silvestrini
state: Umbria
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
state: Veneto
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Panama City
country: Panama
facility: Instituto Oncológico Nacional (ION)
city: Lima
country: Peru
facility: Oncosalud Sac
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Aliada Centro Oncologico
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Vila Nova De Gaia
country: Portugal
facility: CHVNG/E_Unidade 1
city: Alba Iulia
country: Romania
facility: Alba Emergency County Hospital
city: Bucharest
country: Romania
facility: Emergency University Bucharest Hospital
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: Amethyst Cluj
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Timisoara
country: Romania
facility: Centrul de Oncologie Oncohelp
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncological Center
state: Altaj
city: UFA
country: Russian Federation
facility: Bashkirian Republican Clinical Oncology Dispensary
state: Baskortostan
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
state: Krasnodar
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary
state: Moskovskaja Oblast
city: Pesochny
country: Russian Federation
facility: LLC "Oncology scientific centre"
state: Sankt Petersburg
city: Belgrade
country: Serbia
facility: Clinic for Pulmonology, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Sremska Kamenica
country: Serbia
facility: Institute for pulmonary diseases of Vojvodina
city: Adana
country: Turkey
facility: Adana Baskent University Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
city: Ankara
country: Turkey
facility: Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty, Oncology Hospital
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
city: Denizli
country: Turkey
facility: Pamukkale University School Of Medicine
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
city: Izmir
country: Turkey
facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty of Medicine
city: Meram
country: Turkey
facility: Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre
city: Abu Dhabi
country: United Arab Emirates
facility: Mediclinic Airport Road Hospital
city: Dubai
country: United Arab Emirates
facility: Mediclinic City Hospital
city: Montevideo
country: Uruguay
facility: Sanatorio CASMU
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital
city: Hanoi
country: Vietnam
facility: K hospital
city: Hochiminh city
country: Vietnam
facility: Hochiminh city oncology hospital
Study officials:
affiliation: Hoffmann-LaRoche
name: Clinical Trials
role: STUDY_DIRECTOR
References: