Carcinoma, Non-Small-Cell LungALKNCT04947683
Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil
An observational study of Carcinoma, Non-Small-Cell Lung, run by Latin American Cooperative Oncology Group at 5 sites in Brazil.
Trial summary
Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 101 participants
- Where
- 5 sitesBrazil
- Study dates
- 6 Apr 2020to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnostic patients with NSCLC and ALK rearrangement between January 2015 and December 2020.
Who may be able to join
- 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.
Who cannot join
- Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Centro Regional Integrado de Oncologia (CRIO)
Fortaleza, Ceará
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59075-740
CPO Pucrs
Porto Alegre, Rio Grande do Sul
Instituto D'OR
Rio de Janeiro, Rio de Janeiro
A.C Camargo Cancer Center
São Paulo, 01525-001
About this study
Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.
Measured: December of 2020
- Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.
Measured: December of 2020
Secondary outcomes (1)
- Estimate the progression-free survival of first-line treatment, and other subsequent lines;
Measured: December of 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start6 Apr 2020
- Primary completion14 Feb 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947683
- Sponsor's protocol ID
- LACOG 1918
- Acronym
- ALK
- Status last verified
- Aug 2023
- First submitted
- 24 Jun 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil
- ClinicalTrials.gov ID
- NCT04947683
- Acronym / sponsor ID
- ALK / LACOG 1918
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnostic patients with NSCLC and ALK rearrangement between January 2015 and December 2020.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.
Time frame: December of 2020
- Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.
Time frame: December of 2020
1 secondary outcome
- Estimate the progression-free survival of first-line treatment, and other subsequent lines;
Time frame: December of 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Latin American Cooperative Oncology Group at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting. (time frame: December of 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.