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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04764188
Other study ID # MO42122
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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