ALKNCT06652555
The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study
An observational study of ALK and NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Group 1
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 29 Sep 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: ALK-positive NSCLC
Who may be able to join
- Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
- receiving targeted therapy with Lorlatinib
- age ≥18 years old
- follow-up after receipt of Lorlatinib
- voluntarily participate in the study and sign informed consent
Who cannot join
- evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
Read the detailed description
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
- Being tested
- Group 1
- Keywords
- ALK, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
without Intervention
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Baseline characteristics and information during loratinib treatment were collected Receives: Other: Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
The incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib will be reported, such as cognitive effects, mood effects, speech effects and psychotic effects.
Measured: 2 year
Secondary outcomes (3)
To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.
According to the data from CROWN study, management strategies such as to dose interruption, dose reduction or concurrent medication would minimize the impact of CNS AEs effects. However, the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study of China needs to be further clarified.
Measured: 1 year
Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.
The association between baseline characteristics and CNS adverse effects will be evaluated. Baseline characteristics include age, gender, medical history, brain metastases at baseline, previous brain radiation, and lorlatinib treatment lines, among others.
Measured: 1 year
Correlation analysis between CNS AEs occurrence and anti-tumor efficacy
Landmark analysis will be used to investigate the possible association between development of CNS AEs within 24 weeks of initiating lorlatinib and progression-free survival (PFS) as well as the objective response rate (ORR).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion29 Sep 2026 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALKStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxia Su, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chunxia Su, Doctor, Study chair, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652555
- Sponsor's protocol ID
- 2024LY0856
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: research article
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
- ClinicalTrials.gov ID
- NCT06652555
- Acronym / sponsor ID
- 2024LY0856
- Keywords
- ALK, NSCLC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 22 Oct 2024 (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.
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
Detailed description
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: Group 1Baseline characteristics and information during loratinib treatment were collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALK-positive NSCLC
Key inclusion criteria (6 listed)
- Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
- receiving targeted therapy with Lorlatinib
- age ≥18 years old
- follow-up after receipt of Lorlatinib
Key exclusion criteria (2 listed)
- evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1without Intervention | Other | group 1 |
Primary outcome
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
Time frame: 2 year
The incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib will be reported, such as cognitive effects, mood effects, speech effects and psychotic effects.
3 secondary outcomes
To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.
Time frame: 1 year
Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.
Time frame: 1 year
Correlation analysis between CNS AEs occurrence and anti-tumor efficacy
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Yes. research article
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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.
Chunxia Su, Doctor study chair
Shanghai Pulmonary Hospital, Shanghai, China
Questions about this trial
What is this clinical trial studying?
An observational study of ALK and NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, China.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Wang, Doctor (18170211997, leewang8023@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study. (time frame: 2 year). 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 22 Oct 2024.