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OpenTrials
Completed

NCT Number: NCT04227457

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Oncologico Riojano, La Rioja, Rioja, Argentina

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Overall survival of advanced NSCLC in Latin America

    Time frame: Annually, during 3 years

    Time from randomization or initiation of treatment to patient death

Secondary outcomes

  1. Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC

    Time frame: Annually, during 3 years

    Description of the socioeconomical characteristics of the Latin America population with newly advanced NSCLC

  2. Description of pathological profile of advanced NSCLC

    Time frame: Annually, during 3 years

    Analysis of histology and molecular markers of advanced NSCLC

  3. Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC

    Time frame: Annually, during 3 years

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

  4. Description of the treatment responses

    Time frame: Annually, during 3 years

    Description of the treatment responses

  5. Description of Treatment discontinuation

    Time frame: Annually, during 3 years

    Description of the reasons for treatment discontinuation

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Acronym: LATINO Lung

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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