Revisions for An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib | Registro Público Cubano de Ensayos Clínicos

--- 5 August 2021 - 4:36pm by Gladys
+++ 31 August 2021 - 10:58am by Webmaster
-Sofia
+Maria
+Fernanda
-Chaves Chen
+Manavella
-Pharmacy
+Nutritionist
-+506 2298-1585
++506 2298-1000
-Sofia
+Maria
+Fernanda
-Chaves Chen
+Manavella
-Pharmacy
+Nutritionist
-+506 2298-1585
++506 2298-1000
-/08/05
+/08/31
-/08/05
+/08/31
 MO42122
-ReAlec
 NCT04764188

Revision of 31 August 2021 - 10:58am:

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

NCT04764188

Issuing authority of the secondary identifying numbers:

Roche Servicios S.A.

ClinicalTrials.gov

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

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

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:

2021/08/31

Next update date:

2022/08/31

Link to the spanish version:

Click here

Registered Trials

Registration process

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

About the RPCEC

Useful resources