ReAlec: An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04764188
Collaborator
(none)
1,000
126
71
7.9
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date
:
May 10, 2021
Anticipated Primary Completion Date
:
Apr 9, 2027
Anticipated Study Completion Date
:
Apr 9, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Participants starting alectinib treatment before (Arm A) or after (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years. |
Drug: Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
|
| Cohort 2 Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years. |
Drug: Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)]
- 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)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica Adventista Belgrano; Oncology | Ciudad Autonoma Buenos Aires | Argentina | C1430EGF | |
| 2 | Lucen S.A. | Ciudad Autónoma de Buenos Aires | Argentina | C1405CUB | |
| 3 | Lifehouse | Camperdown | New South Wales | Australia | 2050 |
| 4 | Liverpool Hospital; Cancer Therapy Centre | Liverpool | New South Wales | Australia | 2170 |
| 5 | Northern Cancer Institute | St Leonards | New South Wales | Australia | 2065 |
| 6 | Royal North Shore Hospital | St. Leonards | New South Wales | Australia | 2065 |
| 7 | Flinders Medical Centre; Medical Oncology | Bedford Park | South Australia | Australia | 5042 |
| 8 | Peter MacCallum Cancer Center | North Melbourne | Victoria | Australia | 3051 |
| 9 | Klinikum Klagenfurt am Wörtersee | Klagenfurt am Worthersee | Austria | 9020 | |
| 10 | SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung | Wien | Austria | 1140 | |
| 11 | Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie | Wien | Austria | 1210 | |
| 12 | CHIREC | Auderghem | Belgium | 1160 | |
| 13 | AZ Sint Lucas (Sint Lucas) | Gent | Belgium | 9000 | |
| 14 | Jessa Zkh (Campus Virga Jesse) | Hasselt | Belgium | 3500 | |
| 15 | CHU de Liège | Herstal | Belgium | 4040 | |
| 16 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
| 17 | AZ Glorieux- vzw Werken Glorieux | Ronse | Belgium | 9600 | |
| 18 | Vitaz | Sint Niklaas | Belgium | 9100 | |
| 19 | Complex Oncology Center Burgas; Department of medical oncology | Burgas | Bulgaria | ||
| 20 | Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology | Panagyurishte | Bulgaria | 4500 | |
| 21 | Complex Oncology Center - Plovdiv First Internal Chemotherapy Department | Plovdiv | Bulgaria | 4004 | |
| 22 | MBAL Serdika EOOD | Sofia | Bulgaria | 1632 | |
| 23 | Acibadem City Clinic Tokuda; Department of medical oncology | Sofia | Bulgaria | ||
| 24 | Fundacion Arturo Lopez Perez; Quimioterapia | Providencia | Chile | 7500921 | |
| 25 | Centro de Estudios Clínicos SAGA | Santiago | Chile | 7500653 | |
| 26 | Inst. Nacional Del Torax; Pulmonology | Santiago | Chile | ||
| 27 | Hu Nan Provincial Cancer Hospital | Changsha | China | 410006 | |
| 28 | The Second Xiangya Hospital of Central South University | Changsha | China | 410011 | |
| 29 | Sun Yet-sen University Cancer Center | Guangzhou | China | 510060 | |
| 30 | Guangzhou Panyu Central Hospital | Guangzhou | China | ||
| 31 | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou City | China | 310009 | |
| 32 | Anhui Chest Hospital | Hefei | China | ||
| 33 | Shandong Cancer Hospital | Jinan | China | 250117 | |
| 34 | Jiangsu Province Hospital | Nanjing | China | 210036 | |
| 35 | Guangxi Cancer Hospital of Guangxi Medical University | Nanning | China | 530021 | |
| 36 | Shanxi Provincial Cancer Hospital | Taiyuan | China | 030013 | |
| 37 | Shanxi Chinese Medicine Hospital | Taiyuan | China | ||
| 38 | Taizhou Hospital of Zhejiang Province | Taizhou | China | ||
| 39 | Tianjin Cancer Hospital | Tianjin | China | 300060 | |
| 40 | Tianjin Medical University General Hospital; Lung Cancer Surgery Department | Tianjin | China | ||
| 41 | Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center | Wuhan | China | 430023 | |
| 42 | The Affiliated Hospital of Xuzhou Medical College | Xuzhou | China | 221000 | |
| 43 | Henan Provincial People's Hospital | Zhengzhou | China | 450003 | |
| 44 | Hospital Universitario San Ignacio | Bogota | Colombia | 000472 | |
| 45 | Clinica del Country | Bogota | Colombia | 11001 | |
| 46 | Angiografia del Occidente | Cali | Colombia | 760045 | |
| 47 | Instituto Cancerologia Medellin; Clinica Las Americas | Medellin | Colombia | 050024 | |
| 48 | Clinical Hospital Centre Osijek | Osijek | Croatia | 31000 | |
| 49 | Clinical Hospital Centre Zagreb | Zagreb | Croatia | 10000 | |
| 50 | Hospital Hermanos Ameijeiras | La Habana | Cuba | 10300 | |
| 51 | Instituto Nacional de Oncología y Radiología (INOR) | La Habana | Cuba | 10400 | |
| 52 | Masarykův onkologický ústav; Klinika komplexní onkologické péče | Brno | Czechia | 656 53 | |
| 53 | Fakultni nemocnice Olomouc; Pneumologicka klinika | Olomouc | Czechia | 775 20 | |
| 54 | Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN | Praha 4 - Krc | Czechia | 140 59 | |
| 55 | Tampere University Hospital; Dept of Oncology | Tampere | Finland | 33520 | |
| 56 | Turku University Hospital | Turku | Finland | 20521 | |
| 57 | Rambam Health Care Campus; Oncology | Haifa | Israel | 3109601 | |
| 58 | Rabin Medical Center; Oncology Dept | Petach Tikva | Israel | 4941492 | |
| 59 | Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | Israel | 5262100 | |
| 60 | Ichilov Sourasky Medical Center; Heamatology | Tel Aviv | Israel | 6423906 | |
| 61 | Ospedale Clinicizzato SS Annunziata | Chieti | Abruzzo | Italy | 66100 |
| 62 | Grande Ospedale Metropolitano; Oncologia Medica | Reggio Calabria | Calabria | Italy | 89133 |
| 63 | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | Italy | 47014 |
| 64 | Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica | Roma | Lazio | Italy | 00168 |
| 65 | AZ. Ospedaliera San Giovanni - Addolorata | Roma | Lazio | Italy | 00184 |
| 66 | A.O. Villa Scassi; Oncologia Medica | Genova | Liguria | Italy | 16149 |
| 67 | ASST Spedali Civili di Brescia | Brescia | Lombardia | Italy | 25123 |
| 68 | ASST DI CREMONA; Dip. Medicina - S.C. Oncologia | Cremona | Lombardia | Italy | 26100 |
| 69 | Asst Di Monza | Monza | Lombardia | Italy | 20900 |
| 70 | A.O.U. Maggiore della Carità | Novara | Piemonte | Italy | 28100 |
| 71 | Presidio Ospedaliero Centrale; Ospedale S.S. Annunziata | Taranto | Puglia | Italy | 74121 |
| 72 | Ospedale Oncologico A.Businco; Div. Oncologia Medica II | Cagliari | Sardegna | Italy | 09121 |
| 73 | AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello; Dip. Ematologia e Oncologia | Palermo | Sicilia | Italy | 90146 |
| 74 | Ospedale San Jacopo; Dipartimento Oncologico | Pistoia | Toscana | Italy | 51100 |
| 75 | Clinica Oncologica-Ospedali Riuniti Ancona | Torrette | Toscana | Italy | 60020 |
| 76 | Ospedale Silvestrini | Perugia | Umbria | Italy | 06122 |
| 77 | Istituto Oncologico Veneto IRCCS | Padova | Veneto | Italy | 35128 |
| 78 | Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Public Institution | Kaunas | Lithuania | 50009 | |
| 79 | National Cancer Institute; Department of Thoracic Surgery and Oncology | Vilnius | Lithuania | 08660 | |
| 80 | Instituto Oncológico Nacional (ION) | Panama City | Panama | 0816-04433 | |
| 81 | Oncosalud Sac; Oncología | Lima | Peru | 41 | |
| 82 | Instituto Nacional de Enfermedades Neoplasicas | Lima | Peru | Lima 34 | |
| 83 | Aliada Centro Oncologico | Lima | Peru | ||
| 84 | CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo | Coimbra | Portugal | 3000-075 | |
| 85 | Hospital Pulido Valente; Servico de Pneumologia | Lisboa | Portugal | 1796-001 | |
| 86 | Hospital de Sao Joao; Servico de Pneumologia | Porto | Portugal | 4200 | |
| 87 | CHVNG/E_Unidade 1; Servico de Pneumologia | Vila Nova de Gaia | Portugal | 4434-502 | |
| 88 | Alba Emergency County Hospital | Alba Iulia | Romania | 510077 | |
| 89 | Emergency University Bucharest Hospital; Oncology Department | Bucharest | Romania | 050098 | |
| 90 | Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie | Cluj-Napoca | Romania | 400015 | |
| 91 | Amethyst Cluj | Cluj-Napoca | Romania | ||
| 92 | Institutul Regional de Oncologie Iasi | Iasi | Romania | 700483 | |
| 93 | Spitalul Municipal Ploiesti | Ploiesti | Romania | 100337 | |
| 94 | Centrul de Oncologie Oncohelp | Timisoara | Romania | 300239 | |
| 95 | ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic | Barnaul | Altaj | Russian Federation | 656049 |
| 96 | Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | Moskovskaja Oblast | Russian Federation | 454087 |
| 97 | LLC "Oncology scientific centre" | Pesochny | Sankt Petersburg | Russian Federation | 197758 |
| 98 | Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy | Krasnoyarsk | Russian Federation | 660133 | |
| 99 | GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) | Saint Petersburg | Russian Federation | 197758 | |
| 100 | State Healthcare Institution "Regional Clinical Oncology Dispensary" | Saratov | Russian Federation | 410053 | |
| 101 | Bashkirian Republican Clinical Oncology Dispensary | UFA | Russian Federation | 450054 | |
| 102 | Clinic for Pulmonology, Clinical Center of Serbia | Belgrade | Serbia | 11000 | |
| 103 | University Hospital Medical Center Bezanijska kosa | Belgrade | Serbia | 11080 | |
| 104 | Clinical Center Nis; Clinic for pulmonary diseases | Nis | Serbia | 18 000 | |
| 105 | Institute for pulmonary diseases of Vojvodina | Sremska Kamenica | Serbia | 21204 | |
| 106 | Adana Baskent University Hospital; Medical Oncology | Adana | Turkey | 01120 | |
| 107 | Gulhane Training and Research Hospital | Ankara | Turkey | 06010 | |
| 108 | Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi; Medical Oncology | Ankara | Turkey | 06280 | |
| 109 | Gazi University Medical Faculty, Oncology Hospital | Ankara | Turkey | 06500 | |
| 110 | Liv Hospital Ankara; Medical Oncology | Ankara | Turkey | 06680 | |
| 111 | Ankara City Hospital; Oncology | Ankara | Turkey | 06800 | |
| 112 | Antalya Training and Research Hospital ; Oncology Department | Antalya | Turkey | 07100 | |
| 113 | Pamukkale University School Of Medicine; Oncology Department | Denizli | Turkey | 20070 | |
| 114 | Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | Turkey | 22030 | |
| 115 | Medipol University MF; Oncology Department | Istanbul | Turkey | 34214 | |
| 116 | Prof. Dr. Cemil Tascioglu City Hospital; Med Onc | Istanbul | Turkey | 34384 | |
| 117 | Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department | Istanbul | Turkey | 34865 | |
| 118 | Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | Turkey | 35110 | |
| 119 | Inonu University Medical Faculty of Medicine; Medical Oncology Department | Malatya | Turkey | 44280 | |
| 120 | Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi Yunus Emre | Meram | Turkey | 42080 | |
| 121 | Mediclinic Airport Road Hospital | Abu Dhabi | United Arab Emirates | ||
| 122 | Mediclinic City Hospital | Dubai | United Arab Emirates | ||
| 123 | Hospital de Clínicas; Oncolology | Montevideo | Uruguay | ||
| 124 | Sanatorio CASMU; Oncología | Montevideo | Uruguay | ||
| 125 | K hospital | Hanoi | Vietnam | 100000 | |
| 126 | Hochiminh city oncology hospital | Hochiminh city | Vietnam | 700000 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-LaRoche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04764188
Other Study ID Numbers:
- MO42122
First Posted:
Feb 21, 2021
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Hoffmann-La Roche
Additional relevant MeSH terms: