NSCLCPhase 2NCT06772610
The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors
A Phase 2 study testing Ensartinib group in people with NSCLC and ALK, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Ensartinib group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 31 Mar 2032
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years;
- ECOG performance status 0-1;
- Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;
- Confirmed ALK fusion-positive by FISH, IHC, or NGS;
- No prior systemic treatment after surgery;
- At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;
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- Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;
- Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g/L; Absolute neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL/min;
- Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;
- Informed consent obtained from the patient or their legal representative;
- Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.
Who cannot join
- Previous systemic treatment for NSCLC;
- Previous local radiotherapy for NSCLC;
- Unable to take oral medications;
- Known allergy to Ensartinib or any component of this product;
- History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;
- Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;
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- Pregnant or breastfeeding women;
- History of definite neurological or psychiatric disorders, including epilepsy or dementia;
- Any other conditions that the investigator deems unsuitable for enrollment.
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
This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.
Read the detailed description
A total of 40 patients will be enrolled in the study. All patients will receive adjuvant therapy with Ensartinib at a dose of 200 mg, once daily, orally, for a continuous period of 2 years, or until disease recurrence or intolerable toxicity occurs. The efficacy and safety of Ensartinib treatment will be evaluated.Before any study-related procedures are conducted, informed consent will be obtained. Demographic information, a complete medical history, surgical history, and smoking history will be collected. The TNM stage of the primary tumor at diagnosis will be recorded/confirmed. Tumor assessments and other screening examinations required for the screening period will be completed.Ensartinib will be administered at a dose of 200 mg, orally, once daily, for 2 consecutive years. During the first year, efficacy evaluations and safety visits (including physical examinations, laboratory tests, tumor assessments, and quality-of-life assessments) will be conducted every 12 weeks. During the second year and beyond (prior to progression), efficacy evaluations and safety visits will be conducted every 24 weeks.After the study completion by the investigator and the recording of disease progression at each stage, long-term survival follow-up information will be collected every 24 weeks. Patients who discontinue study treatment for reasons other than disease progression (excluding loss to follow-up or death) will continue to undergo objective tumor assessments every 24 weeks to gather information on disease progression. If a patient experiences recurrence within 2 years post-surgery, survival follow-up will be conducted via telephone every 24 weeks after recurrence, continuing until 5 years post-surgery or death.
- Conditions
- NSCLC, ALK, Stage I, Adjuvant Treatment
- Being tested
- Ensartinib group
- Keywords
- NSCLC, ALK positive, adjuvant treatment, high-risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensartinib groupDrug
Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years. Receives: Drug: Ensartinib group |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year disease-free survival rate
2-year DFS rate refers to the percentage of patients who remain free of any signs or symptoms of the disease (in this case, cancer) for two years after receiving treatment.
Measured: up to 2 year
Secondary outcomes (2)
5 year overall survival rate.
The 5 year overall survival rate (5-year OS) is a critical measure in clinical oncology, indicating the percentage of patients who are still alive five years after being diagnosed with cancer or starting treatment.
Measured: up to 5 year
Disease-free survival
Disease-free survival (DFS) is a measure used in clinical oncology to describe the length of time after treatment during which a patient remains free from any signs or symptoms of the disease.
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start15 Mar 2025 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772610
- Sponsor's protocol ID
- 2024LY1286
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 13 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors
- ClinicalTrials.gov ID
- NCT06772610
- Acronym / sponsor ID
- 2024LY1286
- Conditions
- NSCLC, ALK, Stage I, Adjuvant Treatment
- Keywords
- NSCLC, ALK positive, adjuvant treatment, high-risk factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 13 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.
This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.
Detailed description
A total of 40 patients will be enrolled in the study. All patients will receive adjuvant therapy with Ensartinib at a dose of 200 mg, once daily, orally, for a continuous period of 2 years, or until disease recurrence or intolerable toxicity occurs. The efficacy and safety of Ensartinib treatment will be evaluated.Before any study-related procedures are conducted, informed consent will be obtained. Demographic information, a complete medical history, surgical history, and smoking history will be collected. The TNM stage of the primary tumor at diagnosis will be recorded/confirmed. Tumor assessments and other screening examinations required for the screening period will be completed.Ensartinib will be administered at a dose of 200 mg, orally, once daily, for 2 consecutive years. During the first year, efficacy evaluations and safety visits (including physical examinations, laboratory tests, tumor assessments, and quality-of-life assessments) will be conducted every 12 weeks. During the second year and beyond (prior to progression), efficacy evaluations and safety visits will be conducted every 24 weeks.After the study completion by the investigator and the recording of disease progression at each stage, long-term survival follow-up information will be collected every 24 weeks. Patients who discontinue study treatment for reasons other than disease progression (excluding loss to follow-up or death) will continue to undergo objective tumor assessments every 24 weeks to gather information on disease progression. If a patient experiences recurrence within 2 years post-surgery, survival follow-up will be conducted via telephone every 24 weeks after recurrence, continuing until 5 years post-surgery or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Ensartinib groupEnsartinib 200 mg, once daily, orally, for a continuous period of 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years;
- ECOG performance status 0-1;
- Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;
- Confirmed ALK fusion-positive by FISH, IHC, or NGS;
- No prior systemic treatment after surgery;
Key exclusion criteria (9 listed)
- Previous systemic treatment for NSCLC;
- Previous local radiotherapy for NSCLC;
- Unable to take oral medications;
- Known allergy to Ensartinib or any component of this product;
- History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;
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 |
|---|---|---|
| Ensartinib groupEnsartinib 200 mg, once daily, orally, for a continuous period of 2 years. | Drug | Treatment group |
Primary outcome
2 year disease-free survival rate
Time frame: up to 2 year
2-year DFS rate refers to the percentage of patients who remain free of any signs or symptoms of the disease (in this case, cancer) for two years after receiving treatment.
2 secondary outcomes
5 year overall survival rate.
Time frame: up to 5 year
Disease-free survival
Time frame: up to 5 year
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 13 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensartinib group in people with NSCLC and ALK, 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 11 inclusion and 9 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 13 Jan 2025. 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?
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, MD (1817021997, leewang8023@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year disease-free survival rate (time frame: up to 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 13 Jan 2025.