Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil

Carcinoma, Non-Small-Cell Lung Clinical Trial

— ALK  

Official title:

Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947683
• Other study ID #: LACOG 1918
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: March 3, 2023

Study information

• Verified date: August 2023
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 3, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years;
• Newly diagnosed advanced stage IIIB-IV NSCLC (AJCC 8th edition) or locally advance/distant relapse in the period of January 2015 to December 2020.
• NSCLC with pathological confirmation of ALK rearrangement by immunohistochemistry, fluorescent in situ hybridization (FISH) or next generation sequencing (NGS);
• ECOG 0-4;
• Patients with CNS metastases are also considered eligible, regardless of the initial treatment instituted.

Exclusion Criteria:

• Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Brazil	Centro Regional Integrado de Oncologia (CRIO)	Fortaleza	Ceará
Brazil	Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande Do Norte
Brazil	CPO Pucrs	Porto Alegre	RS
Brazil	Instituto D'OR	Rio De Janeiro	RJ
Brazil	A.C Camargo Cancer Center	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	- Estimate the overall survival from diagnosis		December of 2020
Other	- Compare patients' outcomes among baseline characteristics defined subgroups;		December of 2020
Other	- Evaluate health economics parameters in the context.		December of 2020
Primary	- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.		December of 2020
Primary	- Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.		December of 2020
Secondary	- Estimate the progression-free survival of first-line treatment, and other subsequent lines;		December of 2020