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

Completed

• Conditions: Lung Cancer

• Registration Number: NCT04227457
• Lead Sponsor: Latin American Cooperative Oncology Group

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-01-11
• Study Start: 2018-07-25
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Primary Completion: 2021-10-04
• Study Completion: 2023-08-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival of advanced NSCLC in Latin America	Annually, during 3 years	Time from randomization or initiation of treatment to patient death

Secondary Outcome Measures

Name	Time	Method
Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC	Annually, during 3 years	Description of the socioeconomical characteristics of the Latin America population with newly advanced NSCLC
Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC	Annually, during 3 years	Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC
Description of the treatment responses	Annually, during 3 years	Description of the treatment responses
Description of pathological profile of advanced NSCLC	Annually, during 3 years	Analysis of histology and molecular markers of advanced NSCLC
Description of Treatment discontinuation	Annually, during 3 years	Description of the reasons for treatment discontinuation

Trial Locations

Locations (27)

Clínica del Country; 🇨🇴 Chapinero, Bogotá, Colombia

Hospital de Caridade de Carazinho; 🇧🇷 Carazinho, Rio Grande Do Sul, Brazil

Hospital Mãe de Deus; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

HCPA; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Sírio- Libanês; 🇧🇷 Brasília, Distrito Federal, Brazil

CPO; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

AC Camargo; 🇧🇷 São Paulo, Brazil

INCA; 🇧🇷 Rio De Janeiro, Brazil

IBCC; 🇧🇷 São Paulo, Brazil

CLION; 🇧🇷 Salvador, Bahia, Brazil

NOB; 🇧🇷 Salvador, Bahia, Brazil

Hospital de Câncer de Londrina; 🇧🇷 Londrina, Paraná, Brazil

Clínica Reichow; 🇧🇷 Blumenau, Santa Catarina, Brazil

Barretos; 🇧🇷 Barretos, São Paulo, Brazil

COI Américas; 🇧🇷 Rio De Janeiro, Brazil

INCan; 🇲🇽 Ciudad de mexico, Not Aplicable, Mexico

Centro Oncologico Riojano; 🇦🇷 La Rioja, Rioja, Argentina

Instituto De Oncologia De Rosario; 🇦🇷 Santa Fe, Rosário, Argentina

Centro Medico San Roque; 🇦🇷 Córdoba, Tucumán, Argentina

Fundación Arturo López Pérez; 🇨🇱 Providencia, Santiago, Chile

Hospital Pablo Tobon Uribe; 🇨🇴 Robledo, Medellín, Colombia

CRIO; 🇧🇷 Fortaleza, Ceará, Brazil

ICTr; 🇧🇷 Curitiba, Paraná, Brazil

CNT Itajaí; 🇧🇷 Itajaí, Santa Catarina, Brazil

Oncomedica; 🇨🇴 Montería, Córdoba, Colombia

Centro Médico Nacional Siglo XXI; 🇲🇽 Ciudad de mexico, Not Aplicable, Mexico