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An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
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Revisions
Comparing two revisions:
18 August 2021 - 6:31pm
by ROCHE
18 August 2021 - 6:39pm
by ROCHE
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First Name
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Sofia
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Maria
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Fernanda
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Last Name
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Chaves Chen
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Manavella
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Specialty
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Pharmacy
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Nutritionist
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Telephone
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+506 2298-
1585
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+506 2298-
1000
Changes to
First Name
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Sofia
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Maria
Changes to
Middle Name
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Fernanda
Changes to
Last Name
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Chaves Chen
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Manavella
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Specialty
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Pharmacy
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Nutritionist
Changes to
Telephone
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+506 2298-
1585
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+506 2298-
1000
Revision of 18 August 2021 - 6:39pm:
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
ReAlec (MO42122)
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
Acronym of Scientific Title:
ReAlec
Secondary indentifying numbers:
MO42122
ReAlec
NCT04764188
Issuing authority of the secondary identifying numbers:
Roche Servicios S.A.
ClinicalTrials.gov
Primary sponsor:
Roche Servicios S.A.
Secondary sponsor:
Not Applicable
Source(s) of monetary or material support:
Primary Sponsor - Roche Servicios S.A.
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Reference number:
In process
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Haslem
Midle name:
Hassiul
Last name:
Cáceres Lavernia
Medical Specialty :
Medical Doctor, First degree specialist in oncology
Affiliation:
Surgical-Clinic Hospital "Hermanos Ameijeiras" (HHA)
Postal address:
Calle San Lázaro # 701 esq. a Belascoaín
City:
Havana
Country:
Cuba
Zip Code:
10300
Telephone:
+53-52397046
Email address:
hassiul1978@gmail.com
onco@hha.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Argentina
Australia
Austria
Belgium
Bulgaria
Chile
China
Colombia
Croatia
Cuba
Czech Republic
Finland
Israel
Italy
Lithuania
Panama
Peru
Portugal
Romania
Russia
Serbia
Turkey
United Arab Emirates
Uruguay
Vietnam
Clinical sites:
Havana, National Institute of Oncology and Radiobiology (INOR), Dra. Yoanna Flores, Medical Doctor, First degree specialist in oncology.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
13/09/2021
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Non-small cell lung cancer
Health condition(s) code:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Anaplastic Lymphoma Kinase
Intervention(s):
Participants will receive Alectinib in accordance with local clinical practice and local labeling. 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. Cohort 2: Participants receiving Alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
Intervention code:
Observational Study
Intervention keyword:
Alectinib
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. 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). Measurement time: up to 4 years 2. Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2 (Time from the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause). Measurement time: up to 2 years 3. Choice of the Next Line of Treatment (LoT) Post-Alectinib (collection of the commercial name or active principle of the drugs prescribed for the next line of treatment after alectinib documented in the clinical record) Measurement time: Up to approximately 1 year. 4. Duration of Next LoT ( collection of the start date of the first drug administered and the end date of the last drug administered documented in the clinical record during the next line of treatment after alectinib) Measurement time: Up to approximately 1 year 5. Reasons for Discontinuation of Next LoT (collects the reasons for the interruption of the medications of the next line of treatment after alectinib documented in the clinical record) Measurement time: Up to approximately 1 year
Key secondary outcomes:
1. Time to Loss of Clinical Benefit (TTLCB) (Time from the first administration of alectinib until to loss of clinical benefit as assessed by the treating physician). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 2. Overall Survival (OS) (Time from the first administration of alectinib to death from any cause). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 3. Objective Response Rate (ORR) (It is defined as a Complete Response (CR) or Partial Response (PR)). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 4. Time to Response (Time from the first administration of alectinib to first CR or PR). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 5. Duration of Objective Response (DOR) (Time from first documentation of CR or PR (whichever occurs first) after the first administration of alectinib until death or progressive disease (PD)). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 6. Disease Control Rate (DCR) (It is defined as a Complete Response (CR), Partial Response (PR) or Stable Disease (SD)). Measurement time: At least 12 weeks after the first administration of alectinib up to 4 years (Cohort 1) and 2 years (Cohort 2) 7. 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). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 8. Time to Central Nervous System (CNS) Progression-Cohort 1 Arm A (Time from the first administration of alectinib to the date of confirmed CNS metastases in participants with no CNS metastases at baseline). Measurement time: up to 4 years 9. Time to Initiation of Next Line of Treatment (LoT) (Time from the first administration of alectinib to the date of initiation of next LoT or death due to any cause, whichever occurs first). Measurement time: up to 4 years (Cohort 1) and 2 years (Cohort 2) 10. Quality of Life Status (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores). Measurement time: At enrollment and, every 3 months up to 4 years (Cohort 1), and 2 years (Cohort 2) 11. Quality of Life Status (The EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2)). Measurement time: At enrollment and, every 3 months up to 4 years (Cohort 1), and 2 years (Cohort 2)
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
None
Inclusion criteria:
1.- 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. 2.- 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. 3.- Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment. 4.- Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment. 5.- Able to be followed-up by participating site. 6.- Participants with advanced NSCLC who have CNS metastases are eligible for inclusion.
Exclusion criteria:
1.- Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information. 2.- Participants not receiving the Roche studied medicinal product. 3.- Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Observational
Purpose:
Other
Other purpose:
To assess the clinical management of patients with non-small cell lung cancer
Allocation:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Parallel
Phase:
N/A
Target sample size:
1000 global, and 9 in Cuba
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Maria
Middle Name:
Fernanda
Last Name:
Manavella
Specialty:
Nutritionist
Affiliation:
Roche Servicios S.A
Postal Address:
Ultrapark Free Zone, Building 4.
City:
La Aurora de Heredia.
Country:
Costa Rica
Zip Code:
3438-1000
Telephone:
+506 2298-1000
Email :
maria_fernanda.manavella@roche.com
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Maria
Middle Name:
Fernanda
Last Name:
Manavella
Specialty:
Nutritionist
Affiliation:
Roche Servicios S.A
Postal Address:
Ultrapark Free Zone, Building 4.
City:
La Aurora de Heredia
Country:
Costa Rica
Zip Code:
3438-1000
Telephone:
+506 2298-1000
Email :
maria_fernanda.manavella@roche.com
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Hermanos Ameijeiras Hospital
National Institute of Oncology and Radiobiology
Status of evaluation:
In review
In review
Status of evaluation date of Ethic Committee:
28/05/2021
04/06/2021
Postal address of Ethic Committee :
San Lazaro street 701 corner Belascoain, Centro Habana, Havana, ZC 10300, Cuba
Calle 29 corner F, Vedado, Plaza de la Revolucion, Havana, ZC 10400, Cuba
Telephone:
+53-78761000
+53-78382578
Email:
hha@infomed.sld.cu
inor@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Study completion date:
10/05/2025
Date of available results:
31/07/2025
Date of first publication:
14/08/2025
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000387
Date of Registration in Primary Registry:
05/08/2021
Record Verification Date:
2021/08/18
Next update date:
2022/08/18
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