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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Cohort 2 | Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | Participants will receive alectinib in accordance with local clinical practice and local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria
Exclusion Criteria
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Eligible participants will be identified in real-world clinical settings.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-LaRoche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Adventista Belgrano | Ciudad Autonoma Buenos Aires | C1430EGF | Argentina | |||
| Lifehouse |
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
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| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Camperdown |
| New South Wales |
| 2050 |
| Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065000 | Australia |
| GenesisCare North Shore | St Leonards | New South Wales | 2065 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Peter MacCallum Cancer Center | East Melbourne | Victoria | 3002 | Australia |
| Klinikum Klagenfurt am Wörtersee | Klagenfurt | 9020 | Austria |
| Klinik Penzing | Vienna | 1140 | Austria |
| Krankenhaus Nord - Klinik Floridsdorf | Vienna | 1210 | Austria |
| CHIREC | Auderghem | 1160 | Belgium |
| AZ Sint Lucas (Sint Lucas) | Ghent | 9000 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| AZ Glorieux- vzw Werken Glorieux | Ronse | 9600 | Belgium |
| Vitaz | Sint-Niklaas | 9100 | Belgium |
| Complex Oncology Center Burgas | Burgas | Bulgaria |
| Multiprofile Hospital for Active Treatment Uni Hospital | Panagyurishte | 4500 | Bulgaria |
| DDODIU-Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| MBAL Serdika EOOD | Sofia | 1632 | Bulgaria |
| Acibadem City Clinic Tokuda | Sofia | Bulgaria |
| Inst. Nacional Del Torax | Santiago | Santiago Metropolitan | 7500691 | Chile |
| Centro de Estudios Clínicos SAGA | Santiago | 7500653 | Chile |
| Hu Nan Provincial Cancer Hospital | Changsha | 410006 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Guangzhou Panyu Central Hospital | Guangzhou | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | 310009 | China |
| Anhui Chest Hospital | Hefei | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Jiangsu Province Hospital | Nanjing | 210036 | China |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | 530021 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | 030013 | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| Union Hospital of Tongji Medical College, Dept. of Cancer Center | Wuhan | 430023 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | 221004 | China |
| Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo | Bogota, D.C. | 110131 | Colombia |
| Hospital Universitario San Ignacio | Bogotá | 000472 | Colombia |
| Angiografia del Occidente | Cali | 760045 | Colombia |
| Instituto Cancerología Medellin | Medellín | 050024 | Colombia |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Hospital Hermanos Ameijeiras | La Habana | 10300 | Cuba |
| Instituto Nacional de Oncología y Radiología (INOR) | La Habana | 10400 | Cuba |
| Masaryk?v onkologický ústav | Brno | 656 53 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Tampere University Hospital | Tampere | 33520 | Finland |
| Turku University Hospital | Turku | 20521 | Finland |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Ichilov Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Presidio Ospedaliero Centrale | Taranto | Apulia | 74121 | Italy |
| Grande Ospedale Metropolitano | Reggio Calabria | Calabria | 89133 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola | Meldola | Emilia-Romagna | 47014 | Italy |
| Fondazione Ptv Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Policlinico Universitario "Agostino Gemelli" | Rome | Lazio | 00168 | Italy |
| AZ. Ospedaliera San Giovanni - Addolorata | Rome | Lazio | 00184 | Italy |
| A.O. Villa Scassi | Genoa | Liguria | 16149 | Italy |
| ASST Spedali Civili di Brescia | Brescia | Lombardy | 25123 | Italy |
| Asst Di Cremona | Cremona | Lombardy | 26100 | Italy |
| A.O.U. Maggiore della Carità | Novara | Piedmont | 28100 | Italy |
| Ospedale Oncologico A.Businco | Cagliari | Sardinia | 09121 | Italy |
| AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello | Palermo | Sicily | 90146 | Italy |
| Ospedale San Jacopo | Pistoia | Tuscany | 51100 | Italy |
| Clinica Oncologica-Ospedali Riuniti Ancona | Torrette | Tuscany | 60020 | Italy |
| Ospedale Silvestrini | Perugia | Umbria | 06122 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | Veneto | 35128 | Italy |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution | Kaunas | 50009 | Lithuania |
| National Cancer Institute | Vilnius | LT-08660 | Lithuania |
| Instituto Oncológico Nacional (ION) | Panama City | 0816-04433 | Panama |
| Aliada Centro Oncologico | Lima | 15036 | Peru |
| Oncosalud Sac | Lima | 41 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | Lima 34 | Peru |
| Hospital de Sao Joao | Porto | 4200 | Portugal |
| CHVNG/E_Unidade 1 | Vila Nova de Gaia | 4434-502 | Portugal |
| Alba Emergency County Hospital | Alba Iulia | 510077 | Romania |
| Emergency University Bucharest Hospital | Bucharest | 050098 | Romania |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Amethyst Cluj | Cluj-Napoca | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Spitalul Municipal Ploiesti | Ploieşti | 100337 | Romania |
| Centrul de Oncologie Oncohelp | Timișoara | 300239 | Romania |
| Altai Regional Oncological Center | Barnaul | Altayskiy Kray | 656049 | Russia |
| Bashkirian Republican Clinical Oncology Dispensary | Ufa | Bashkortostan Republic | 450054 | Russia |
| Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky | Krasnoyarsk | Krasnodarskiy Kray | 660133 | Russia |
| Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | Moscow Oblast | 454087 | Russia |
| Medical Clinic "AB Medical group" | Saint Petersburg | Sankt-Peterburg | 196006 | Russia |
| Clinic for Pulmonology, Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| University Hospital Medical Center Bezanijska kosa | Belgrade | 11080 | Serbia |
| Institute for pulmonary diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| Clinical Center Nis | Niš | 18 000 | Serbia |
| Adana Baskent University Hospital | Adana | 01120 | Turkey (Türkiye) |
| Gulhane Training and Research Hospital | Ankara | 06010 | Turkey (Türkiye) |
| Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi | Ankara | 06280 | Turkey (Türkiye) |
| Gazi University Medical Faculty, Oncology Hospital | Ankara | 06500 | Turkey (Türkiye) |
| Liv Hospital Ankara | Ankara | 06680 | Turkey (Türkiye) |
| Ankara City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Antalya Training and Research Hospital | Antalya | 07100 | Turkey (Türkiye) |
| Pamukkale University School Of Medicine | Denizli | 20070 | Turkey (Türkiye) |
| Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | 22030 | Turkey (Türkiye) |
| Kartal Dr Lutfi Kirdar Sehir Hastanesi | Istanbul | 34000 | Turkey (Türkiye) |
| Medipol University Medical Faculty | Istanbul | 34214 | Turkey (Türkiye) |
| Prof. Dr. Cemil Tascioglu City Hospital | Istanbul | 34384 | Turkey (Türkiye) |
| Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | 35110 | Turkey (Türkiye) |
| Inonu University Medical Faculty of Medicine | Malatya | 44280 | Turkey (Türkiye) |
| Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre | Meram | 42080 | Turkey (Türkiye) |
| Mediclinic Airport Road Hospital | Abu Dhabi | United Arab Emirates |
| Mediclinic City Hospital | Dubai | 31500 | United Arab Emirates |
| Sanatorio CASMU | Montevideo | Uruguay |
| Hanoi Oncology Hospital | Hanoi | 100000 | Vietnam |
| K hospital | Hanoi | 100000 | Vietnam |
| Hochiminh city oncology hospital | Hochiminh City | 700000 | Vietnam |
| ID | Term |
|---|---|
| C582670 | alectinib |
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