ALK PositiveNCT06736561
A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.
An observational study of ALK Positive and Ensartinib, run by Harbin Medical University.
Trial summary
Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK Positive, Ensartinib, NSCLC
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2028
- How long will I take part?
- 2 Years
- 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+
Who may be able to join
- Cohort 1: Female or male aged >=18 years;
- Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;
- Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
- Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.
- Cohort 2: Female or male aged >=18 years;
- Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;
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- Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
- Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
- Cohort 2: Signed informed consent form;
- Cohort 3: Female or male aged >=18 years;
- Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;
- Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;
- Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
- Cohort 3: Signed informed consent form.
Who cannot join
- Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
- Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- Cohort 1: Patients who are participating in other clinical studies outside of this research;
- Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
- Cohort 2: Patients who have received Ensartinib treatment before the study started;
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- Cohort 2: Patients who have received other systemic treatments besides Ensartinib;
- Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;
- Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- Cohort 2: Patients who are participating in other clinical studies outside of this research;
- Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.
- Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;
- Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- Cohort 3: Patients who are participating in other clinical studies outside of this research;
- Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.
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
Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.
- Conditions
- ALK Positive, Ensartinib, NSCLC, Neoadjuvant Therapy
- Keywords
- ALK Positive, Ensartinib, NSCLC, Neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Data on the efficacy and safety of patients who had previously used enshatinib in the neoadjuvant phase were retrospectively collected | |
| Cohort 2 | Akl-positive patients received enshatinib monotherapy neoadjuvant therapy for 6-12 weeks | |
| Cohort 3 | Alk-positive patients received neoadjuvant therapy that included enshatinib and did not meet cohort 2 inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
Main pathological remission rate
Measured: 6month
Secondary outcomes (3)
pCR
Pathological complete response rate
Measured: 6month
2-year disease-free survival rate
2-year disease-free survival rate
Measured: 2year
ORR
Objective response rate
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK PositiveStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqun Ma, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736561
- Sponsor's protocol ID
- 2024-275-IIT
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.
- ClinicalTrials.gov ID
- NCT06736561
- Acronym / sponsor ID
- 2024-275-IIT
- Conditions
- ALK Positive, Ensartinib, NSCLC, Neoadjuvant Therapy
- Keywords
- ALK Positive, Ensartinib, NSCLC, Neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Dec 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.
Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Data on the efficacy and safety of patients who had previously used enshatinib in the neoadjuvant phase were retrospectively collected |
| Cohort 2 | – | –Akl-positive patients received enshatinib monotherapy neoadjuvant therapy for 6-12 weeks |
| Cohort 3 | – | –Alk-positive patients received neoadjuvant therapy that included enshatinib and did not meet cohort 2 inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALK+
Key inclusion criteria (14 listed)
- Cohort 1: Female or male aged >=18 years;
- Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;
- Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
- Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.
- Cohort 2: Female or male aged >=18 years;
Key exclusion criteria (17 listed)
- Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
- Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- Cohort 1: Patients who are participating in other clinical studies outside of this research;
- Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
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
MPR
Time frame: 6month
Main pathological remission rate
3 secondary outcomes
pCR
Time frame: 6month
2-year disease-free survival rate
Time frame: 2year
ORR
Time frame: 1year
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 16 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ALK Positive and Ensartinib, run by Harbin Medical University.
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 14 inclusion and 17 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 16 Dec 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 Ma (86+ 18646101888, jianqunma@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR (time frame: 6month). 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 16 Dec 2024.