NSCLC, Stage I, II, IIIA, IIIBPhase 2NCT06780839
Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD
A Phase 2 study testing Ensartinib in people with NSCLC, Stage I, II, IIIA, IIIB, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To explore the efficacy and safety of ensartinib on adjuvant therapy guided by MRD in IA3-IIIB (T3N2) stage ALK-positive non-small cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage I, II, IIIA, IIIB
- What is being tested?
- Ensartinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 15 Jan 2030
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed primary non-small cell lung cancer;
- Age ≥18 years old, gender unlimited;
- The stage of the disease was based on AJCC/UICC 8th edition of lung cancer staging criteria; Complete surgical resection (R0) of primary lung cancer with Stage IA3 with high-risk recurrence factors, stage IB, II, IIIA, and IIIB (T3N2M0 only) of non-small cell lung were pathological confirmed;
- Full recovery from surgery;
- The biopsy or postoperative tumor tissue samples tested by the local laboratory are positive for ALK, and can be accepted by IHC, RT-PCR, FISH and NGS test results;
- Intended to receive enshatinib postoperative adjuvant therapy;
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- ECOG physical status score is 0-1;
- Has good hematopoietic and organ function, and the laboratory test values;
- Participants with active hepatitis B or hepatitis C are allowed to be enrolled, provided that they receive strict antiviral therapy prior to medication and that liver function is adequate;
- Syphilitic positive subjects are allowed to be enrolled, but strictly standardized anti-syphilis therapy is required before medication and syphilitic heart disease and other serious complications are excluded;
- Fertile female subjects must have a negative serum pregnancy test at the time of screening and during at the end of the study; Male subjects whose partners are women of reproductive age should be surgically sterilized, or effective methods of contraception should be given during and at the end of the study;
- Sign informed consent, voluntarily and be able to comply with the procedures of the trial and follow-up.
Who cannot join
- Participating in a clinical study and receiving investigational drug therapy or investigational device within 4 weeks prior to initial dosing; If involved in non-interventional clinical trials can be included in this study;
- There is unresectable or metastatic disease, pathology report showing microscopic positive surgical margin or extranodal invasion.
- History of other malignancies within 5 years prior to the first dose of the study drug, except for malignancies that are expected to be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery);
- Previous treatment for NSCLC, including chemotherapy (preoperative chemotherapy treatment ≤ 2 cycles is allowed), targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, ALK, VEGFR and other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc.;
- The subject has undergone major surgery within 3 weeks prior to the first dose of the study drug (including primary tumor surgery, thoracotomy, laparotomy, excluding vascular access establishment procedures);
- Use of traditional Chinese medicine and Chinese medicine preparations with anti-tumor treatment indications or auxiliary therapeutic effects on tumors within 14 days prior to the first dose of the study drug;
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- Received strong CYP3A inhibitors or inducers and narrow therapeutic index CYP3A substrates within 14 days before the first dose of the study drug;
- Clinically significant cardiovascular diseases；
- Severe active infection, interstitial lung disease / pneumonia, or any other serious underlying disease that may affect the subject's acceptance of protocol treatment within 2 weeks before the first dose;
- Positive HIV antibody test result;
- Active pulmonary tuberculosis;
- Pregnant or lactating women;
- Any other clinically significant disease or condition that the investigator believes may affect protocol compliance or the subject's signing of the informed consent form, or is not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shi Yan contact
China1 site
Beijing cancer hospital
Beijing, Beijing Municipality, 100000
Nan Wu, +86-010-88196391, nanwu@bjmu.edu.cn
About this study
Official title: Postoperative Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD: a Single-arm, Multicenter Study
To explore the efficacy and safety of ensartinib on adjuvant therapy guided by MRD in IA3-IIIB (T3N2) stage ALK-positive non-small cell lung cancer patients.
Read the detailed description
Eligible subjects will take ensartinib 225 mg once daily. Postoperative tissues will be collected for customized minimal residual disease (MRD) detection (tumor-informed MRD). MRD tests will be conducted within 14 to 50 days after surgery (before adjuvant therapy), every 12 weeks ± 7 days for the first two years, and every 24 weeks ± 7 days for the third year. Subjects with negative MRD after surgery will receive ensartinib treatment. If MRD turns positive, they will receive ensartinib 225 mg QD combined with platinum-based doublet chemotherapy (2 to 4 cycles) as a step-up treatment. Subjects with positive MRD after surgery will also receive ensartinib treatment. If MRD remains positive at the next MRD test, they will receive ensartinib 225 mg QD combined with platinum-based doublet chemotherapy (2 to 4 cycles) as a step-up treatment. If MRD turns negative during treatment, ensartinib monotherapy will be resumed. If MRD turns positive again, the subsequent treatment mode will be determined by the MDT discussion group composed of the main center researchers, including but not limited to monotherapy or combination with platinum-free chemotherapy until 3 years, or MRD turns negative, or intolerable toxicity, or radiological recurrence, whichever occurs first. For patients who remain MRD positive after 3 years of treatment, the MDT group will discuss the next steps.
- Conditions
- NSCLC, Stage I, II, IIIA, IIIB
- Being tested
- Ensartinib
- Keywords
- NSCLC, ALK positive, MRD, adjuvant therapy
- 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.
EnsartinibDrug
Patients will receive Ensartinib 225mg QD by MRD test guided, if MRD test shows negative, only ensartinib will be given. if MRD test turns from negative to posive, patients will receive step-up treatment, which is ensartibe plus platinum - based doublet chemotherapy no more than 4 cycles. If MRD test turns from posive to negative, only ensartinib will be given. if MRD test constantly shows positive, MDT will determine the next step ensartib-based therapy.
| Study group | Role | What they receive |
|---|---|---|
| ensartinib | Experimental | Not described Receives: Drug: Ensartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
From enrollment to until the date of first documented progression or date of death from any cause, whichever came first
Measured: From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (1)
Adverse events
adverse events using common terminology criteria for adverse events 5.0
Measured: From enrollment to until the date up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage I, II, IIIA, IIIBStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Responsible party
- Principal investigator, Wu Nan, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780839
- Sponsor's protocol ID
- BD-EN-IV025
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 17 Jan 2025
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD: a Single-arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT06780839
- Acronym / sponsor ID
- BD-EN-IV025
- Conditions
- NSCLC, Stage I, II, IIIA, IIIB
- Keywords
- NSCLC, ALK positive, MRD, adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 17 Jan 2025 (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.
To explore the efficacy and safety of ensartinib on adjuvant therapy guided by MRD in IA3-IIIB (T3N2) stage ALK-positive non-small cell lung cancer patients.
Detailed description
Eligible subjects will take ensartinib 225 mg once daily. Postoperative tissues will be collected for customized minimal residual disease (MRD) detection (tumor-informed MRD). MRD tests will be conducted within 14 to 50 days after surgery (before adjuvant therapy), every 12 weeks ± 7 days for the first two years, and every 24 weeks ± 7 days for the third year. Subjects with negative MRD after surgery will receive ensartinib treatment. If MRD turns positive, they will receive ensartinib 225 mg QD combined with platinum-based doublet chemotherapy (2 to 4 cycles) as a step-up treatment. Subjects with positive MRD after surgery will also receive ensartinib treatment. If MRD remains positive at the next MRD test, they will receive ensartinib 225 mg QD combined with platinum-based doublet chemotherapy (2 to 4 cycles) as a step-up treatment. If MRD turns negative during treatment, ensartinib monotherapy will be resumed. If MRD turns positive again, the subsequent treatment mode will be determined by the MDT discussion group composed of the main center researchers, including but not limited to monotherapy or combination with platinum-free chemotherapy until 3 years, or MRD turns negative, or intolerable toxicity, or radiological recurrence, whichever occurs first. For patients who remain MRD positive after 3 years of treatment, the MDT group will discuss the next steps.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ensartinib | Experimental | Drug: Ensartinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed primary non-small cell lung cancer;
- Age ≥18 years old, gender unlimited;
- The stage of the disease was based on AJCC/UICC 8th edition of lung cancer staging criteria; Complete surgical resection (R0) of primary lung cancer with Stage IA3 with high-risk recurrence factors, stage IB, II, IIIA, and IIIB (T3N2M0 only) of non-small cell lung were pathological confirmed;
- Full recovery from surgery;
- The biopsy or postoperative tumor tissue samples tested by the local laboratory are positive for ALK, and can be accepted by IHC, RT-PCR, FISH and NGS test results;
Key exclusion criteria (13 listed)
- Participating in a clinical study and receiving investigational drug therapy or investigational device within 4 weeks prior to initial dosing; If involved in non-interventional clinical trials can be included in this study;
- There is unresectable or metastatic disease, pathology report showing microscopic positive surgical margin or extranodal invasion.
- History of other malignancies within 5 years prior to the first dose of the study drug, except for malignancies that are expected to be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery);
- Previous treatment for NSCLC, including chemotherapy (preoperative chemotherapy treatment ≤ 2 cycles is allowed), targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, ALK, VEGFR and other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc.;
- The subject has undergone major surgery within 3 weeks prior to the first dose of the study drug (including primary tumor surgery, thoracotomy, laparotomy, excluding vascular access establishment procedures);
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 |
|---|---|---|
| EnsartinibPatients will receive Ensartinib 225mg QD by MRD test guided, if MRD test shows negative, only ensartinib will be given. if MRD test turns from negative to posive, patients will receive step-up treatment, which is ensartibe plus platinum - based doublet chemotherapy no more than 4 cycles. If MRD test turns from posive to negative, only ensartinib will be given. if MRD test constantly shows positive, MDT will determine the next step ensartib-based therapy. | Drug | ensartinib |
Primary outcome
DFS
Time frame: From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
From enrollment to until the date of first documented progression or date of death from any cause, whichever came first
1 secondary outcome
Adverse events
Time frame: From enrollment to until the date up to 60 months
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 17 Jan 2025.
- 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.
Shi Yan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensartinib in people with NSCLC, Stage I, II, IIIA, IIIB, run by Peking University Cancer Hospital & Institute at 1 site in 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 12 inclusion and 13 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
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 Nan Wu (+86-010-88196391, nanwu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months). 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 17 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.