Carcinoma, Non-Small-Cell LungPhase 2NCT06697990
Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients
A Phase 2 study testing Iruplinalib in people with Carcinoma, Non-Small-Cell Lung, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Iruplinalib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Mar 2026
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
- Confirmed diagnosis of brain metastases or suspected brain metastases
- Iruplinalib is proposed for treatment
- Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
- Adequate organ and marrow function
Who cannot join
- Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
- The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
- The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
- Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism
About this study
Official title: Exploring the Mechanism of Cerebrospinal Fluid Immune Microenvironment in Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Lung Cancer With Brain Metastases Treated With Iruplinalib: an Interventional Study
This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Iruplinalib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IruplinalibDrug
Also called WX-0593
60 mg of Iruplinalib, once daily for 7 days, followed by 180 mg of Iruplinalib, once daily in a 28-days cycle.
| Study group | Role | What they receive |
|---|---|---|
| Iruplinalib | Experimental | The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator. Receives: Drug: Iruplinalib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
Cerebrospinal fluid levels of natural killer (NK) cells,CD3+ T cells,CD4+ T cells,CD8+ T cells,tumour necrosis factor alpha(TNF-α), interleukin-6(IL-6), interferon-gamma(IFN-γ), high C-reactive protein(hs-CRP),immunoglobulin A(IgA),immunoglobulin E(IgE),immunoglobulin G(IgG),immunoglobulin M(IgM),intercellular adhesion molecule 1(ICAM-1) and vascular cell adhesion molecule 1(VCAM-1).
Measured: 28 days
Secondary outcomes (5)
Iruplinalib concentration in cerebrospinal fluid
Iruplinalib concentration in cerebrospinal fluid.
Measured: Day 28
Objective response rate
Objective response rate is defined as the percentage of participants who have a complete response or partial response.
Measured: 16 weeks
Disease control rate
Disease control rate is defined as the percentage of participants who have a best overall response of complete response, partial response, or stable disease.
Measured: 16 weeks
Intracranial objective response rate
Intracranial objective response rate is defined as above for objective Response Rate but it is only based on intracranial disease in the subset of patients with intracranial lesion.
Measured: 16 weeks
Intracranial disease control rate
Intracranial disease control rate is defined as above for disease control rate but it is only based on intracranial disease in the subset of patients with intracranial lesion.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
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.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697990
- Sponsor's protocol ID
- QLMA-NSCLC-IIT-001
- Status last verified
- Aug 2024
- First submitted
- 17 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanism of Cerebrospinal Fluid Immune Microenvironment in Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Lung Cancer With Brain Metastases Treated With Iruplinalib: an Interventional Study
- ClinicalTrials.gov ID
- NCT06697990
- Acronym / sponsor ID
- QLMA-NSCLC-IIT-001
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Nov 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.
This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iruplinalib | Experimental | Drug: IruplinalibThe treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
- Confirmed diagnosis of brain metastases or suspected brain metastases
- Iruplinalib is proposed for treatment
- Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
- Adequate organ and marrow function
Key exclusion criteria (4 listed)
- Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
- The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
- The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
- Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism
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 |
|---|---|---|
| IruplinalibAlso: WX-059360 mg of Iruplinalib, once daily for 7 days, followed by 180 mg of Iruplinalib, once daily in a 28-days cycle. | Drug | Iruplinalib |
Primary outcome
Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
Time frame: 28 days
Cerebrospinal fluid levels of natural killer (NK) cells,CD3+ T cells,CD4+ T cells,CD8+ T cells,tumour necrosis factor alpha(TNF-α), interleukin-6(IL-6), interferon-gamma(IFN-γ), high C-reactive protein(hs-CRP),immunoglobulin A(IgA),immunoglobulin E(IgE),immunoglobulin G(IgG),immunoglobulin M(IgM),intercellular adhesion molecule 1(ICAM-1) and vascular cell adhesion molecule 1(VCAM-1).
5 secondary outcomes
Iruplinalib concentration in cerebrospinal fluid
Time frame: Day 28
Objective response rate
Time frame: 16 weeks
Disease control rate
Time frame: 16 weeks
Intracranial objective response rate
Time frame: 16 weeks
Intracranial disease control rate
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iruplinalib in people with Carcinoma, Non-Small-Cell Lung, run by Tianjin Medical University Cancer Institute and Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules (time frame: 28 days). 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 20 Nov 2024.