Non-Small Cell Lung CancerPhase 2NCT06779539
Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer
A Phase 2 study testing Ensartinib in people with Non-Small Cell Lung Cancer, run by West China Hospital.
Trial summary
This single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Ensartinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 12 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give written informed consent before any study procedure.
- Male or female aged between 18 and 75 years old (including 18 and 75 years old).
- Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.
- Clinical stage II-III assessed by EBUS-TBNA or PET/CT can be resected.
- Patients confirmed as ALK fusion positive by RBK (NGS) test.
- Presence of at least one accurately measurable lesion, CT showing a maximum diameter of 10mm at baseline (except for lymph nodes with a short axis of 15mm required) and suitable for accurate repeat measurements.
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- Eastern Cooperative Oncology Group (ECOG) performance status （PS） of 0 or 1.
- Adequate hematological, biochemical and organ functions, defined as follows
- Hemoglobin ≥90g/L. Note: transfusions are allowed to meet the required hemoglobin level;
- Absolute neutrophil count (ANC) ≥1.5× 10^9/L
- Platelets ≥90 × 10^9/L;
- Total bilirubin ≤ 2 times the upper limit of normal (ULN)；
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN;
- Creatinine ≤ 1.5× ULN and creatinine clearance ≥ 60 mL/min.
- Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis);
- At least 2 weeks prior to initial trial treatment female subjects should use adequate contraceptive measures, the pregnancy test must be negative and there is no ongoing breastfeeding. Otherwise, one of the following criteria must be met during screening to prove the possibility of no fertility:
- Postmenopausal is defined as amenorrhea for at least 12 months after stopping all exogenous hormone treatment over 50 years old;
- Women under the age of 50 should be regarded as menopause if they stop menopause for 12 months or more after stopping exogenous sex hormone therapy, and their LH and FSH levels are within the postmenopausal range of the institution;
- Irreversible surgical sterilization recorded by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but excluding tubal ligation.
- Men with partners of childbearing potential willing to use adequate contraceptive measures during the study and for 3 months after the last dose of study medication.
Who cannot join
- Mixed squamous cell carcinoma, large cell neuroendocrine carcinoma or small cell lung cancer;
- Prior treatment with any anti-cancer therapy;
- Pregnant female patients; breastfeeding female patients.
- Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior). All patients must try to avoid using or ingesting any drugs, herbal supplements and/or foods that are known to have induced effects on CYP3A4.
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) or known human immunodeficiency virus (HIV). Screening for chronic diseases is not a requirement.
- Past medical history of Interstitial lung disease（ILD）, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
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- A history of hypersensitivity to active or inactive excipients of Ensartinib or to drugs of similar chemical structure or class to Ensartinib, and uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow drugs, or had undergone major bowel resection that would interfere with adequate absorption of Ensartinib.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc)>470 msec, obtained from 3 electrocardiograms (ECGs)
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third-degree heart block, second-degree heart block.
- Any factors that increase the risk of QTc prolongation or the risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
- A clear past history of neurological or psychiatric disorders, including epilepsy or dementia；
- Other circumstances deemed inappropriate by the investigator for participation in the trial.
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: A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer：A Prospective, Open-label, Multi-center, Single-arm, Phase II Clinical Trial
This single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients.
Read the detailed description
This is a single-Arm, prospective, multicenter, phase II study, the primary endpoint is pathological complete response (pCR). Participants will receive ensartinib at 225 mg orally once a day taken with or without food for 12 weeks before surgical resection.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Ensartinib
- 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
Ensartinib 225 mg oral once daily 12 weeks
| 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.
Pathological complete response (pCR) rate
pCR rate is defined as the proportion of participants who have achieved pathologic complete response (with no residual viable tumor in lung primary or lymph nodes as evaluated by central pathology laboratory of surgical specimens) in all participants.
Measured: Within 2 month after surgery
Secondary outcomes (5)
Major Pathological Response (MPR) rate
MPR rate is defined as the proportion of participants who have achieved major pathologic response (less than or equal to 10% of residual viable tumor in lung primary or lymph nodes as evaluated by central pathology laboratory of surgical specimens) in all participants.
Measured: Within 2 month after surgery
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who attained complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator.
Measured: Pre-operation
Incidence of Adverse Events
Toxicity will be graded by NCI Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Measured: Up to 1 month after surgery
Disease free survival (DFS)
DFS is defined as the time from the first day after radical surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.
Measured: 3 years postoperatively
Overall Survival (OS)
OS was defined as the time from the date of enrollment to death from any cause.
Measured: 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion12 Jun 2028 (estimated)
- Study completion12 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by West China 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qinghua, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779539
- Sponsor's protocol ID
- CLOG-0003
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer：A Prospective, Open-label, Multi-center, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06779539
- Acronym / sponsor ID
- CLOG-0003
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 12 Jun 2028 (estimated)
- Study completion
- 12 Dec 2030 (estimated)
- First posted
- 16 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 single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients.
Detailed description
This is a single-Arm, prospective, multicenter, phase II study, the primary endpoint is pathological complete response (pCR). Participants will receive ensartinib at 225 mg orally once a day taken with or without food for 12 weeks before surgical resection.
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 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Give written informed consent before any study procedure.
- Male or female aged between 18 and 75 years old (including 18 and 75 years old).
- Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.
- Clinical stage II-III assessed by EBUS-TBNA or PET/CT can be resected.
- Patients confirmed as ALK fusion positive by RBK (NGS) test.
Key exclusion criteria (13 listed)
- Mixed squamous cell carcinoma, large cell neuroendocrine carcinoma or small cell lung cancer;
- Prior treatment with any anti-cancer therapy;
- Pregnant female patients; breastfeeding female patients.
- Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior). All patients must try to avoid using or ingesting any drugs, herbal supplements and/or foods that are known to have induced effects on CYP3A4.
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) or known human immunodeficiency virus (HIV). Screening for chronic diseases is not a requirement.
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 |
|---|---|---|
| EnsartinibEnsartinib 225 mg oral once daily 12 weeks | Drug | Ensartinib |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Within 2 month after surgery
pCR rate is defined as the proportion of participants who have achieved pathologic complete response (with no residual viable tumor in lung primary or lymph nodes as evaluated by central pathology laboratory of surgical specimens) in all participants.
5 secondary outcomes
Major Pathological Response (MPR) rate
Time frame: Within 2 month after surgery
Objective Response Rate (ORR)
Time frame: Pre-operation
Incidence of Adverse Events
Time frame: Up to 1 month after surgery
Disease free survival (DFS)
Time frame: 3 years postoperatively
Overall Survival (OS)
Time frame: 5 years postoperatively
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.
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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 in people with Non-Small Cell Lung Cancer, run by West China 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 20 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.
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 Qinghua Zhou (028-85422114, Prof._QH.Zhou_GCP@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Within 2 month after surgery). 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.