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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04764188




Registration number
NCT04764188
Ethics application status
Date submitted
5/02/2021
Date registered
21/02/2021

Titles & IDs
Public title
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
Scientific 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)
Secondary ID [1] 0 0
MO42122
Universal Trial Number (UTN)
Trial acronym
ReAlec
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Alectinib

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.


Treatment: Drugs: Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1
Timepoint [1] 0 0
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 outcome [2] 0 0
Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2
Timepoint [2] 0 0
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 outcome [3] 0 0
Choice of the Next Line of Treatment (LoT) Post-Alectinib
Timepoint [3] 0 0
Up to approximately 1 year
Primary outcome [4] 0 0
Duration of Next LoT
Timepoint [4] 0 0
Up to approximately 1 year
Primary outcome [5] 0 0
Reasons for Discontinuation of Next LoT
Timepoint [5] 0 0
Up to approximately 1 year
Secondary outcome [1] 0 0
Time to Loss of Clinical Benefit (TTLCB)
Timepoint [1] 0 0
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 outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
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 outcome [3] 0 0
Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR)
Timepoint [3] 0 0
From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2)
Secondary outcome [4] 0 0
Time to Response
Timepoint [4] 0 0
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 outcome [5] 0 0
Duration of Objective Response (DOR)
Timepoint [5] 0 0
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 outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Secondary outcome [7] 0 0
Duration of Disease Control
Timepoint [7] 0 0
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 outcome [8] 0 0
Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A)
Timepoint [8] 0 0
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 outcome [9] 0 0
Time to Initiation of Next Line of Treatment (LoT)
Timepoint [9] 0 0
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 outcome [10] 0 0
Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
Timepoint [10] 0 0
At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Secondary outcome [11] 0 0
Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2)
Timepoint [11] 0 0
At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/05/2027
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital; Cancer Therapy Centre - Liverpool
Recruitment hospital [3] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
Flinders Medical Centre; Medical Oncology - Bedford Park
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3051 - North Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad Autonoma Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Klagenfurt am Worthersee
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Auderghem
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Hasselt
Country [7] 0 0
Belgium
State/province [7] 0 0
Kortrijk
Country [8] 0 0
Belgium
State/province [8] 0 0
Liège
Country [9] 0 0
Belgium
State/province [9] 0 0
Ronse
Country [10] 0 0
Belgium
State/province [10] 0 0
Sint Niklaas
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Burgas
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Panagyurishte
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Plovdiv
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
China
State/province [16] 0 0
Changsha
Country [17] 0 0
China
State/province [17] 0 0
Guangzhou City
Country [18] 0 0
China
State/province [18] 0 0
Guangzhou
Country [19] 0 0
China
State/province [19] 0 0
Hangzhou City
Country [20] 0 0
China
State/province [20] 0 0
Hefei
Country [21] 0 0
China
State/province [21] 0 0
Jinan
Country [22] 0 0
China
State/province [22] 0 0
Nanjing
Country [23] 0 0
China
State/province [23] 0 0
Nanning City
Country [24] 0 0
China
State/province [24] 0 0
Taiyuan
Country [25] 0 0
China
State/province [25] 0 0
Taizhou
Country [26] 0 0
China
State/province [26] 0 0
Tianjin
Country [27] 0 0
China
State/province [27] 0 0
Wuhan
Country [28] 0 0
China
State/province [28] 0 0
Xuzhou
Country [29] 0 0
China
State/province [29] 0 0
Zhengzhou
Country [30] 0 0
Colombia
State/province [30] 0 0
Bogota, D.C.
Country [31] 0 0
Colombia
State/province [31] 0 0
Bogota
Country [32] 0 0
Colombia
State/province [32] 0 0
Cali
Country [33] 0 0
Colombia
State/province [33] 0 0
Medellin
Country [34] 0 0
Croatia
State/province [34] 0 0
Osijek
Country [35] 0 0
Croatia
State/province [35] 0 0
Zagreb
Country [36] 0 0
Cuba
State/province [36] 0 0
La Habana
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Olomouc
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 4 - Krc
Country [40] 0 0
Finland
State/province [40] 0 0
Tampere
Country [41] 0 0
Finland
State/province [41] 0 0
Turku
Country [42] 0 0
Israel
State/province [42] 0 0
Haifa
Country [43] 0 0
Israel
State/province [43] 0 0
Petah Tikva
Country [44] 0 0
Israel
State/province [44] 0 0
Ramat Gan
Country [45] 0 0
Israel
State/province [45] 0 0
Tel Aviv
Country [46] 0 0
Italy
State/province [46] 0 0
Abruzzo
Country [47] 0 0
Italy
State/province [47] 0 0
Lazio
Country [48] 0 0
Italy
State/province [48] 0 0
Lombardia
Country [49] 0 0
Italy
State/province [49] 0 0
Piemonte
Country [50] 0 0
Italy
State/province [50] 0 0
Puglia
Country [51] 0 0
Italy
State/province [51] 0 0
Sardegna
Country [52] 0 0
Italy
State/province [52] 0 0
Sicilia
Country [53] 0 0
Italy
State/province [53] 0 0
Toscana
Country [54] 0 0
Italy
State/province [54] 0 0
Umbria
Country [55] 0 0
Italy
State/province [55] 0 0
Veneto
Country [56] 0 0
Lithuania
State/province [56] 0 0
Kaunas
Country [57] 0 0
Lithuania
State/province [57] 0 0
Vilnius
Country [58] 0 0
Panama
State/province [58] 0 0
Panama City
Country [59] 0 0
Peru
State/province [59] 0 0
Lima
Country [60] 0 0
Portugal
State/province [60] 0 0
Porto
Country [61] 0 0
Portugal
State/province [61] 0 0
Vila Nova de Gaia
Country [62] 0 0
Romania
State/province [62] 0 0
Alba Iulia
Country [63] 0 0
Romania
State/province [63] 0 0
Bucharest
Country [64] 0 0
Romania
State/province [64] 0 0
Cluj-Napoca
Country [65] 0 0
Romania
State/province [65] 0 0
Iasi
Country [66] 0 0
Romania
State/province [66] 0 0
Ploiesti
Country [67] 0 0
Romania
State/province [67] 0 0
Timisoara
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Altaj
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Baskortostan
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Krasnodar
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Moskovskaja Oblast
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Sankt Petersburg
Country [73] 0 0
Serbia
State/province [73] 0 0
Belgrade
Country [74] 0 0
Serbia
State/province [74] 0 0
Nis
Country [75] 0 0
Serbia
State/province [75] 0 0
Sremska Kamenica
Country [76] 0 0
Turkey
State/province [76] 0 0
Adana
Country [77] 0 0
Turkey
State/province [77] 0 0
Ankara
Country [78] 0 0
Turkey
State/province [78] 0 0
Antalya
Country [79] 0 0
Turkey
State/province [79] 0 0
Denizli
Country [80] 0 0
Turkey
State/province [80] 0 0
Edirne
Country [81] 0 0
Turkey
State/province [81] 0 0
Istanbul
Country [82] 0 0
Turkey
State/province [82] 0 0
Izmir
Country [83] 0 0
Turkey
State/province [83] 0 0
Malatya
Country [84] 0 0
Turkey
State/province [84] 0 0
Meram
Country [85] 0 0
United Arab Emirates
State/province [85] 0 0
Abu Dhabi
Country [86] 0 0
United Arab Emirates
State/province [86] 0 0
Dubai
Country [87] 0 0
Uruguay
State/province [87] 0 0
Montevideo
Country [88] 0 0
Vietnam
State/province [88] 0 0
Hanoi
Country [89] 0 0
Vietnam
State/province [89] 0 0
Hochiminh city

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-LaRoche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04764188