Clinical trial NCT04227457: Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
Official title: Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2020-01-13
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival of advanced NSCLC in Latin America
timeFrame: Annually, during 3 years
Secondary outcomes:
measure: Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC
timeFrame: Annually, during 3 years
measure: Description of pathological profile of advanced NSCLC
timeFrame: Annually, during 3 years
measure: Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC
timeFrame: Annually, during 3 years
measure: Description of the treatment responses
timeFrame: Annually, during 3 years
measure: Description of Treatment discontinuation
timeFrame: Annually, during 3 years
Other outcomes:
Locations:
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano
state: Rioja
city: Santa Fe
country: Argentina
facility: Instituto De Oncologia De Rosario
state: Rosário
city: Córdoba
country: Argentina
facility: Centro Medico San Roque
state: Tucumán
city: Salvador
country: Brazil
facility: CLION
state: Bahia
city: Salvador
country: Brazil
facility: NOB
state: Bahia
city: Fortaleza
country: Brazil
facility: CRIO
state: Ceará
city: Brasília
country: Brazil
facility: Hospital Sírio- Libanês
state: Distrito Federal
city: Curitiba
country: Brazil
facility: ICTr
state: Paraná
city: Londrina
country: Brazil
facility: Hospital de Câncer de Londrina
state: Paraná
city: Carazinho
country: Brazil
facility: Hospital de Caridade de Carazinho
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CPO
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: HCPA
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clínica Reichow
state: Santa Catarina
city: Itajaí
country: Brazil
facility: CNT Itajaí
state: Santa Catarina
city: Barretos
country: Brazil
facility: Barretos
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: COI Américas
city: Rio De Janeiro
country: Brazil
facility: INCA
city: São Paulo
country: Brazil
facility: AC Camargo
city: São Paulo
country: Brazil
facility: IBCC
city: Providencia
country: Chile
facility: Fundación Arturo López Pérez
state: Santiago
city: Chapinero
country: Colombia
facility: Clínica del Country
state: Bogotá
city: Montería
country: Colombia
facility: Oncomedica
state: Córdoba
city: Robledo
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Medellín
city: Ciudad de mexico
country: Mexico
facility: Centro Médico Nacional Siglo XXI
state: Not Aplicable
city: Ciudad de mexico
country: Mexico
facility: INCan
state: Not Aplicable
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Carlos Barrios
role: PRINCIPAL_INVESTIGATOR
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky
role: PRINCIPAL_INVESTIGATOR
References: