NCT04227457

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
5 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

January 11, 2018

Last Update Submit

February 18, 2024

Conditions

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival of advanced NSCLC in Latin America

    Time from randomization or initiation of treatment to patient death

    Annually, during 3 years

Secondary Outcomes (5)

  • Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC

    Annually, during 3 years

  • Description of pathological profile of advanced NSCLC

    Annually, during 3 years

  • Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC

    Annually, during 3 years

  • Description of the treatment responses

    Annually, during 3 years

  • Description of Treatment discontinuation

    Annually, during 3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The LATINO Lung study will prospectively recruit a minimum of 700 and up to 800 patients with advanced NSCLC, including locally advanced disease not amenable to curative treatment or metastatic disease from sites in Argentina, Brazil, Chile, Colombia, and Mexico. Other countries may be invited to participate. Patients will be recruited during an initial study period of 3 months, or more to reach the study minimum sample size, and will be followed for 3 years.

You may qualify if:

  • Patients aged 18 years or older;
  • 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);
  • Histologically or cytologically confirmed advanced NSCLC:
  • Stage IIIB that progressed after curative therapy (chemoradiation and/or surgery);
  • Stage IV metastatic disease (de novo or distant relapse)
  • Any NSCLC histological subtype and molecular mutation;
  • Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
  • Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy) or palliative care;
  • Access to patient medical chart for data collection;
  • Willing and able to provide written informed consent and privacy authorization for the release of personal health information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Centro Oncologico Riojano

La Rioja, Rioja, Argentina

Location

Instituto De Oncologia De Rosario

Santa Fe, Rosário, Argentina

Location

Centro Medico San Roque

Córdoba, Tucumán Province, Argentina

Location

CRIO

Fortaleza, Ceará, Brazil

Location

CLION

Salvador, Estado de Bahia, Brazil

Location

NOB

Salvador, Estado de Bahia, Brazil

Location

Hospital Sírio- Libanês

Brasília, Federal District, Brazil

Location

ICTr

Curitiba, Paraná, Brazil

Location

Hospital de Câncer de Londrina

Londrina, Paraná, Brazil

Location

Hospital de Caridade de Carazinho

Carazinho, Rio Grande do Sul, Brazil

Location

CPO

Porto Alegre, Rio Grande do Sul, Brazil

Location

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Location

Clínica Reichow

Blumenau, Santa Catarina, Brazil

Location

CNT Itajaí

Itajaí, Santa Catarina, Brazil

Location

Barretos

Barretos, São Paulo, Brazil

Location

COI Américas

Rio de Janeiro, Brazil

Location

INCA

Rio de Janeiro, Brazil

Location

AC Camargo

São Paulo, Brazil

Location

IBCC

São Paulo, Brazil

Location

Fundación Arturo López Pérez

Providencia, Santiago Metropolitan, Chile

Location

Clínica del Country

Chapinero, Bogota D.C., Colombia

Location

Oncomedica

Montería, Departamento de Córdoba, Colombia

Location

Hospital Pablo Tobon Uribe

Robledo, Medellín, Colombia

Location

Centro Médico Nacional Siglo XXI

Mexico City, Not Aplicable, Mexico

Location

INCan

Mexico City, Not Aplicable, Mexico

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Carlos Barrios

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR
  • Gustavo Werutsky

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 13, 2020

Study Start

July 25, 2018

Primary Completion

October 4, 2021

Study Completion

August 4, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations