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CompletedNCT04947683ALKUpdated Aug 2, 2023

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

An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Latin American Cooperative Oncology Group. Completed at 5 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by Latin American Cooperative Oncology Group · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
101
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • Carcinoma
  • Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 101 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Latin American Cooperative Oncology Group is the lead sponsor of 47 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
101 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. - Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.

    Time frame: December of 2020

  2. - Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.

    Time frame: December of 2020

Secondary outcomes

  1. - Estimate the progression-free survival of first-line treatment, and other subsequent lines;

    Time frame: December of 2020

Other outcomes

  1. - Estimate the overall survival from diagnosis

    Time frame: December of 2020

  2. - Compare patients' outcomes among baseline characteristics defined subgroups;

    Time frame: December of 2020

  3. - Evaluate health economics parameters in the context.

    Time frame: December of 2020

07

Study locations

5 sites
  • Centro Regional Integrado de Oncologia (CRIO)
    Fortaleza, Ceará, Brazil
  • Instituto D'OR
    Rio de Janeiro, Rio de Janeiro, Brazil
  • Liga Norte Riograndense Contra o Câncer
    Natal, Rio Grande do Norte 59075-740, Brazil
  • CPO Pucrs
    Porto Alegre, Rio Grande do Sul, Brazil
  • A.C Camargo Cancer Center
    São Paulo, 01525-001, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04947683
Lead sponsor
Latin American Cooperative Oncology Group
Responsible party
Sponsor
First posted
Jul 1, 2021
Start date
Apr 6, 2020
Primary completion
Feb 14, 2023
Completion
Mar 3, 2023
Last update
Aug 2, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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