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

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01525-001
    • A.C Camargo Cancer Center
  • Ceará
    • Fortaleza, Ceará, Brazil
      • Centro Regional Integrado de Oncologia (CRIO)
  • RJ
    • Rio De Janeiro, RJ, Brazil
      • Instituto D'OR
  • RS
    • Porto Alegre, RS, Brazil
      • CPO Pucrs
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Liga Norte Riograndense Contra O Câncer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diagnostic patients with NSCLC and ALK rearrangement between January 2015 and December 2020.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.	December of 2020
- Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.	December of 2020

Secondary Outcome Measures

Outcome Measure	Time Frame
- Estimate the progression-free survival of first-line treatment, and other subsequent lines;	December of 2020

Other Outcome Measures

Outcome Measure	Time Frame
- Estimate the overall survival from diagnosis	December of 2020
- Compare patients' outcomes among baseline characteristics defined subgroups;	December of 2020
- Evaluate health economics parameters in the context.	December of 2020

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Carcinoma; Non-Small-Cell Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LACOG 1918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No