ALK-positive Advanced NSCLCPhase 4NCT06785584
Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study
A Phase 4 study testing Ensartinib in people with ALK-positive Advanced NSCLC and ALK-positive Non-small Cell Lung Cancer (NSCLC), run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR
- What is being tested?
- Ensartinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Dec 2025
- Phase
- Phase 4
- 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
- Age ≥18
- Histologically or cytologically confirmed lung adenocarcinoma
- Evaluated resectable TNM stage IIA-IIIB (operable or potentially operable) non-small cell lung cancer (NSCLC)
- Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods，before treatment with ALK inhibitors
- Measurable lesions were determined with the use of the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria) on CT scans
- Magnetic resonance imaging (MRI) or CT scans of the brain show no metastatic disease
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- Tumors contained components of squamous cell carcinoma, large-cell neuroendocrine carcinoma, or small-cell carcinoma
- Severe infections, including COVID-19, including but not limited to hospitalization due to complications of infection within the 4 weeks prior to starting study treatment
- Have not received chemotherapy, radiotherapy, or biological therapy
- Hemoglobin ≥100 g/L(which can be maintained or exceeded by blood transfusion); Absolute neutrophil count ≥2.0×109/L; Platelet count ≥100×109/L
- Total bilirubin ≤1.5 times upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; CREA ≤1.5 times the upper limit of normal and CREA clearance ≥60mL/min
- Women of childbearing age (15 to 49 years) must undergo a urine pregnancy test within 7 days before starting treatment and the result is negative
- Informed consent is obtained from patients or their legal representatives
- Able to swallow oral medications normally
- ECOG behavior status score is 0 to 1
- Men and women of reproductive age agree to use a reliable method of contraception before entering the trial, during the study and up to eight weeks after discontinuation
- Stable health status, including no acute exacerbations of chronic diseases, serious infections, or major surgeries during the first 4 weeks of enrollment, as indicated in other inclusion/exclusion criteria
Who cannot join
- Have received any systemic anti-cancer treatment for locally advanced non-small cell lung cancer, including chemotherapy, biotherapy (including ALK-TKI), immunotherapy, or any investigational drug
- PET-CT scan or biopsy results showing unresectable stage III and IV disease with distant metastasis (including malignant pleural effusion)
- Patients who had a cancer other than NSCLC within 5 years before the initiation of study treatment
- Allergy to ensartinib or any of the ingredients in this product
- Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;Baseline CT scans found idiopathic pulmonary fibrosis
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow preparations, or previous major bowel resection resulting in inadequate absorption of ensartinib
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- Any unstable systemic illness, including active infection, uncontrolled hypertension, unstable angina, angina with onset within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] class II), myocardial infarction (within 6 months before enrollment), severe arrhythmias requiring medical therapy, or hepatic, renal, or metabolic disease
- Human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
- A definite past history of neurological or psychiatric disorders, including epilepsy or dementia
- History of organ transplantation
- Rheumatic immune-related diseases
- Other cases that the researcher deemed unsuitable for enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350100
Guanglei Huang, +86 18059776417, 1318718218@qq.com
About this study
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer.
Surgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients.
Read more
In the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients.
Many studies have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC.
The investigators designed this study to explore the efficacy of enshatinib neoadjuvant therapy in patients with stage IIA to III ALK-positive lung adenocarcinoma
Read the detailed description
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). The statistics of the National Cancer Center of China shows that there are about 1 061 thousand new cases and 733 thousand deaths of lung cancer in China every year, which account for the first incidence and mortality of malignant tumors in China. According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer.
Surgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients.
In the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients.
Many studies such as The SAKULA study,The ALNEO Study have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC.
Ensartinib is a novel potent and highly selective second-generation ALK inhibitor, which has a good selective inhibition effect on c-Met. Structurally, Ensartinib is similar to crizotinib, but Ensartinib has stronger binding to ALK and better selectivity than crizotinib, and both in vitro and in vivo experiments have shown the potential of ensartinib for crizotinib-resistant tumors.
The safety profile of ensartinib was manageable. In the eXalt3 study, the most common adverse events of all grades in the ensartinib group were rash, pruritus, and elevated aminotransferase (ALT, AST).
The eXalt3 study confirmed that first-line use of ensartinib can significantly improve mPFS compared with crizotinib in ALK-positive NSCLC patients, and ensartinib provides better efficacy and safety, making it a new first-line treatment option for ALK-positive NSCLC patients.
ALK inhibitors have brought great survival benefits to ALK-positive advanced NSCLC, but the exploration of ALK inhibitors in early-stage patients has just begun,with no authoritative results have been published. TThe investigators designed this study to explore the efficacy of neoadjuvant treatment with ensartinib in patients with stage IIA-IIB ALK-positive lung adenocarcinoma who had undergone neoadjuvant chemotherapy for ALK mutation.
The primary goal of this study is to evaluate the major pathological response (MPR) to neoadjuvant ensartinib in patients with resectable stage IIA to IIIb ALK-positive non-small cell lung cancer (NSCLC).
The secondary objectives are to evaluate the complete pathological response (pCR), objective response rate (ORR), and safety of neoadjuvant ensartinib in patients with resectable stage IIA-IIIb ALK-positive non-small cell lung cancer (NSCLC)
- Conditions
- ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR, Neoadjuvant Therapy
- Being tested
- Ensartinib
- Keywords
- Ensartinib, Neoadjuvant Therapy, ALK-Positive Lung Adenocarcinoma, MPR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsartinibDrug
receive neoadjuvant treatment with ensartinib 225 mg once a day, po. for 2 consecutive cycles (56 days) to evaluate possibility of surgery, or discontinue the treatment because of disease recurrence or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Ensartinib For Neoadjuvant Therapy | Experimental | receive neoadjuvant treatment with ensartinib 225 mg once a day, po. for 2 consecutive cycles (56 days) to evaluate possibility of surgery, or discontinue the treatment because of disease recurrence or intolerable toxicity Receives: Drug: Ensartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate(MPR)
The proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and metastatic lymph nodes after completion of neoadjuvant therapy
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
Pathological complete response rate (pCR)
Proportion of patients who had no residual tumor in the resected primary tumor and metastatic lymph nodes after completion of neoadjuvant therapy
Measured: From enrollment to the end of treatment at 8 weeks
Objective Response Rate (ORR)
The proportion of patients with a complete response (CR) or partial response (PR) among all patients, as assessed according to RECIST, version 1.1
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-positive Advanced NSCLCStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785584
- Sponsor's protocol ID
- 2024ENT01
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study
- ClinicalTrials.gov ID
- NCT06785584
- Acronym / sponsor ID
- 2024ENT01
- Conditions
- ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR, Neoadjuvant Therapy
- Keywords
- Ensartinib, Neoadjuvant Therapy, ALK-Positive Lung Adenocarcinoma, MPR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 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.
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer.
Surgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients.
In the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients.
Many studies have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC.
The investigators designed this study to explore the efficacy of enshatinib neoadjuvant therapy in patients with stage IIA to III ALK-positive lung adenocarcinoma
Detailed description
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). The statistics of the National Cancer Center of China shows that there are about 1 061 thousand new cases and 733 thousand deaths of lung cancer in China every year, which account for the first incidence and mortality of malignant tumors in China. According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer.
Surgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients.
In the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients.
Many studies such as The SAKULA study,The ALNEO Study have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC.
Ensartinib is a novel potent and highly selective second-generation ALK inhibitor, which has a good selective inhibition effect on c-Met. Structurally, Ensartinib is similar to crizotinib, but Ensartinib has stronger binding to ALK and better selectivity than crizotinib, and both in vitro and in vivo experiments have shown the potential of ensartinib for crizotinib-resistant tumors.
The safety profile of ensartinib was manageable. In the eXalt3 study, the most common adverse events of all grades in the ensartinib group were rash, pruritus, and elevated aminotransferase (ALT, AST).
The eXalt3 study confirmed that first-line use of ensartinib can significantly improve mPFS compared with crizotinib in ALK-positive NSCLC patients, and ensartinib provides better efficacy and safety, making it a new first-line treatment option for ALK-positive NSCLC patients.
ALK inhibitors have brought great survival benefits to ALK-positive advanced NSCLC, but the exploration of ALK inhibitors in early-stage patients has just begun,with no authoritative results have been published. TThe investigators designed this study to explore the efficacy of neoadjuvant treatment with ensartinib in patients with stage IIA-IIB ALK-positive lung adenocarcinoma who had undergone neoadjuvant chemotherapy for ALK mutation.
The primary goal of this study is to evaluate the major pathological response (MPR) to neoadjuvant ensartinib in patients with resectable stage IIA to IIIb ALK-positive non-small cell lung cancer (NSCLC).
The secondary objectives are to evaluate the complete pathological response (pCR), objective response rate (ORR), and safety of neoadjuvant ensartinib in patients with resectable stage IIA-IIIb ALK-positive non-small cell lung cancer (NSCLC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensartinib For Neoadjuvant Therapy | Experimental | Drug: Ensartinibreceive neoadjuvant treatment with ensartinib 225 mg once a day, po. for 2 consecutive cycles (56 days) to evaluate possibility of surgery, or discontinue the treatment because of disease recurrence or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18
- Histologically or cytologically confirmed lung adenocarcinoma
- Evaluated resectable TNM stage IIA-IIIB (operable or potentially operable) non-small cell lung cancer (NSCLC)
- Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods，before treatment with ALK inhibitors
- Measurable lesions were determined with the use of the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria) on CT scans
Key exclusion criteria (13 listed)
- Have received any systemic anti-cancer treatment for locally advanced non-small cell lung cancer, including chemotherapy, biotherapy (including ALK-TKI), immunotherapy, or any investigational drug
- PET-CT scan or biopsy results showing unresectable stage III and IV disease with distant metastasis (including malignant pleural effusion)
- Patients who had a cancer other than NSCLC within 5 years before the initiation of study treatment
- Allergy to ensartinib or any of the ingredients in this product
- Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;Baseline CT scans found 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 |
|---|---|---|
| Ensartinibreceive neoadjuvant treatment with ensartinib 225 mg once a day, po. for 2 consecutive cycles (56 days) to evaluate possibility of surgery, or discontinue the treatment because of disease recurrence or intolerable toxicity | Drug | Ensartinib For Neoadjuvant Therapy |
Primary outcome
Major pathological response rate(MPR)
Time frame: From enrollment to the end of treatment at 8 weeks
The proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and metastatic lymph nodes after completion of neoadjuvant therapy
2 secondary outcomes
Pathological complete response rate (pCR)
Time frame: From enrollment to the end of treatment at 8 weeks
Objective Response Rate (ORR)
Time frame: From enrollment to the end of treatment at 8 weeks
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 21 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ensartinib in people with ALK-positive Advanced NSCLC and ALK-positive Non-small Cell Lung Cancer (NSCLC), run by Fujian Medical University Union Hospital 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 17 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 21 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Guanglei Huang (+86 18059776417, 1318718218@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate(MPR) (time frame: From enrollment to the end of treatment at 8 weeks). 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 21 Jan 2025.