Lung CancerLATINO LungNCT04227457
Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
An observational study of Lung Cancer, run by Latin American Cooperative Oncology Group at 27 sites in 5 countries.
Trial summary
To describe the overall survival of advanced NSCLC in Latin America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 700 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 25 Jul 2018to 4 Aug 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
Brazil18 sites
Barretos
Barretos, São Paulo
Clínica Reichow
Blumenau, Santa Catarina
Hospital Sírio- Libanês
Brasília, Federal District
Hospital de Caridade de Carazinho
Carazinho, Rio Grande do Sul
ICTr
Curitiba, Paraná
CRIO
Fortaleza, Ceará
CNT Itajaí
Itajaí, Santa Catarina
Hospital de Câncer de Londrina
Londrina, Paraná
CPO
Porto Alegre, Rio Grande do Sul
HCPA
Porto Alegre, Rio Grande do Sul
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul
COI Américas
Rio de Janeiro
INCA
Rio de Janeiro
CLION
Salvador, Estado de Bahia
NOB
Salvador, Estado de Bahia
AC Camargo
São Paulo
IBCC
São Paulo
Argentina3 sites
Centro Medico San Roque
Córdoba, Tucumán Province
Centro Oncologico Riojano
La Rioja, Rioja
Instituto De Oncologia De Rosario
Santa Fe, Rosário
Colombia3 sites
Clínica del Country
Chapinero, Bogota D.C.
Oncomedica
Montería, Departamento de Córdoba
Hospital Pablo Tobon Uribe
Robledo, Medellín
Mexico2 sites
Centro Médico Nacional Siglo XXI
Mexico City, Not Aplicable
INCan
Mexico City, Not Aplicable
About this study
To describe the overall survival of advanced NSCLC in Latin America.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of advanced NSCLC in Latin America
Time from randomization or initiation of treatment to patient death
Measured: Annually, during 3 years
Secondary outcomes (5)
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
Measured: Annually, during 3 years
Description of pathological profile of advanced NSCLC
Analysis of histology and molecular markers of advanced NSCLC
Measured: Annually, during 3 years
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
Measured: Annually, during 3 years
Description of the treatment responses
Description of the treatment responses
Measured: Annually, during 3 years
Description of Treatment discontinuation
Description of the reasons for treatment discontinuation
Measured: Annually, during 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start25 Jul 2018
- Primary completion4 Oct 2021
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Carlos Barrios, Principal investigator, Latin American Cooperative Oncology GroupGustavo Werutsky, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227457
- Sponsor's protocol ID
- LACOG 0116
- Acronym
- LATINO Lung
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
- ClinicalTrials.gov ID
- NCT04227457
- Acronym / sponsor ID
- LATINO Lung / LACOG 0116
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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:
- Any NSCLC histological subtype and molecular mutation;
- Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival of advanced NSCLC in Latin America
Time frame: Annually, during 3 years
Time from randomization or initiation of treatment to patient death
5 secondary outcomes
Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC
Time frame: Annually, during 3 years
Description of pathological profile of advanced NSCLC
Time frame: Annually, during 3 years
Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC
Time frame: Annually, during 3 years
Description of the treatment responses
Time frame: Annually, during 3 years
Description of Treatment discontinuation
Time frame: Annually, during 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Barrios principal investigator
Latin American Cooperative Oncology Group
Gustavo Werutsky principal investigator
Latin American Cooperative Oncology Group
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Latin American Cooperative Oncology Group at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Brazil, Argentina, Colombia, Mexico, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of advanced NSCLC in Latin America (time frame: Annually, during 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.