Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America

Lung Cancer Clinical Trial

— LATINO Lung  

Official title:

Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227457
• Other study ID #: LACOG 0116
• Status: Completed
• Start date: July 25, 2018
• Est. completion date: August 4, 2023

Study information

• Verified date: February 2024
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To describe the overall survival of advanced NSCLC in Latin America.

Description:

• To describe demographic and socioeconomic characteristics of patients newly diagnosed with advanced NSCLC

• To describe diagnostic methods, pathological profile and disease stage at diagnosis of advanced NSCLC

• To describe the practice patterns of therapeutic agents for treatment of advanced NSCLC

• To describe treatment responses, progression and survival times.

• To describe reasons for treatment discontinuation

• To identify associations between patient demographics, socioeconomic, pathology, treatment sequences and overall survival;

• To define the patient experience of advanced NSCLC and identify unmet needs in their diagnose and treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: August 4, 2023
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 18 years or older;

2. Newly diagnosed Non-Small Cell Lung Cancer (NSCLC) during the period of the study (which includes 3 months prior to site activation by LACOG, although they can have received anti-cancer treatment during that time);

3. Histologically or cytologically confirmed advanced NSCLC:

1. Stage IIIB that progressed after curative therapy (chemoradiation and/or surgery);

2. Stage IV metastatic disease (de novo or distant relapse)

4. Any NSCLC histological subtype and molecular mutation;

5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;

6. Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy) or palliative care;

7. Access to patient medical chart for data collection;

8. Willing and able to provide written informed consent and privacy authorization for the release of personal health information.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Argentina	Centro Medico San Roque	Córdoba	Tucumán
Argentina	Centro Oncologico Riojano	La Rioja	Rioja
Argentina	Instituto De Oncologia De Rosario	Santa Fe	Rosário
Brazil	Barretos	Barretos	São Paulo
Brazil	Clínica Reichow	Blumenau	Santa Catarina
Brazil	Hospital Sírio- Libanês	Brasília	Distrito Federal
Brazil	Hospital de Caridade de Carazinho	Carazinho	Rio Grande Do Sul
Brazil	ICTr	Curitiba	Paraná
Brazil	CRIO	Fortaleza	Ceará
Brazil	CNT Itajaí	Itajaí	Santa Catarina
Brazil	Hospital de Câncer de Londrina	Londrina	Paraná
Brazil	CPO	Porto Alegre	Rio Grande Do Sul
Brazil	HCPA	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Mãe de Deus	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	COI Américas	Rio De Janeiro
Brazil	INCA	Rio De Janeiro
Brazil	CLION	Salvador	Bahia
Brazil	NOB	Salvador	Bahia
Brazil	AC Camargo	São Paulo
Brazil	IBCC	São Paulo
Chile	Fundación Arturo López Pérez	Providencia	Santiago
Colombia	Clínica del Country	Chapinero	Bogotá
Colombia	Oncomedica	Montería	Córdoba
Colombia	Hospital Pablo Tobon Uribe	Robledo	Medellín
Mexico	Centro Médico Nacional Siglo XXI	Ciudad de mexico	Not Aplicable
Mexico	INCan	Ciudad de mexico	Not Aplicable

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Bristol-Myers Squibb

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of advanced NSCLC in Latin America	Time from randomization or initiation of treatment to patient death	Annually, during 3 years
Secondary	Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC	Description of the socioeconomical characteristics of the Latin America population with newly advanced NSCLC	Annually, during 3 years
Secondary	Description of pathological profile of advanced NSCLC	Analysis of histology and molecular markers of advanced NSCLC	Annually, during 3 years
Secondary	Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC	Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC	Annually, during 3 years
Secondary	Description of the treatment responses	Description of the treatment responses	Annually, during 3 years
Secondary	Description of Treatment discontinuation	Description of the reasons for treatment discontinuation	Annually, during 3 years