ALK Fusion Protein ExpressionPhase 2NCT05186506
A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
A Phase 2 study testing Ensatinib and chemotherapy in people with ALK Fusion Protein Expression and Adjuvant Therapy, run by Sichuan University.
Trial summary
This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer
- What is being tested?
- Ensatinib and chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 20 Dec 2028
- 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 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical resection of histologically confirmed Stage IIA to IIIA NSCLC with negative margins, ,within 10 weeks after the operation
- Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
- At least 3-months life expectancy
- Adequate organ function
- Any major surgery should be completed at least 4 weeks before the first study drug treatment. Minor surgery/procedures must be completed at least 2 weeks before taking medication.
- Willingness and ability to comply with the trial and follow-up procedures
- Written informed consents are required to indicate that the patients are aware of the investigational nature of the study
Who cannot join
- More than 10 weeks before surgery Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Use of other investigational drug within 4 weeks prior to the first dose of Ensartinib
- Prior stem cell or organ transplant
- severe cardiovascular disease
- Presence of active gastrointestinal (GI) disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of Ensartinib
- Active hepatitis B, hepatitis C virus antibody positive, HIV virus antibody, Treponema pallidum antibody positive
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- History of interstitial lung disease, drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid therapy, or any clinical signs of active interstitial lung disease
- Reproductive or pregnant or breastfeeding female with a positive serum pregnancy test 7 days before starting treatment , Male or female patients failure to take effective contraceptive measures or plan to give birth during the entire treatment period and 3 months after treatment ends
- Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib or to the active ingredient of ensartinib
- History of drug allergy, such as a history of allergies to pemetrexed, carboplatin or other platinum compounds, or their preventive medications; History of allergies to paclitaxel components; or uncontrolled asthma
- Patients who have used the following drugs within 14 days before the first dose or who need to use the following drugs during treatment: drugs that cause QTc prolongation and/or torsade de pointes-type ventricular tachycardia; strong inhibitors or strong inducers of CYP3A
- Patients being treated with warfarin or any other coumarin derivative anticoagulant
- According to the judgment of the investigator, other severe, acute or chronic medical conditions that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results
- Concurrent condition evaluated by investigator that would make it inappropriate for the patient to be enrolled
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 Phase II, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection
Read the detailed description
Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day (QD) taken with food for 2 years. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Treatments will continue until disease recurrence, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy), or achieving a maximum treatment duration of 2 years. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
- Being tested
- Ensatinib, chemotherapy
- 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.
EnsatinibDrug
Also called X-396
225 mg administered once daily orally for two years.
chemotherapyDrug
Pemetrexed : Participants will receive 500 mg/m^2, day 1 , Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Cisplatin :Participants will receive 75 mg/m^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Paclitaxel: Participants will receive 175 mg/ m^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
carboplatin AUC= 5 mg/ mL/min, intravenously guttae, day 1 ,Q21D ，until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Ensatinib | Experimental | 225 mg administered once daily orally for two years. Receives: Drug: Ensatinib |
| Platinum-Based Chemotherapy | Active comparator | Patients in the chemotherapy group were allowed to cross into the Ensatinib treatment group after the disease progressed. Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Measured: From date of randomization until date of the first observation of tumor recurrence, metastasis (based on imaging ) or death, up to approximately 5 years.
Secondary outcomes (4)
DFS at 2 years
Measured: Assessed at 2 years
DFS at 3 years
Measured: Assessed at 3 years
Overall survival (OS)
Measured: The time from the date of randomization to death from any cause, up to approximately 7 years
OS rate at 5 years
Measured: Assessed at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK Fusion Protein ExpressionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Responsible party
- Principal investigator, You Lu, Sichuan University
- Investigators
- You Lu, MD, Study chair, Sichuan UniversityMeijuan Huang, MD, Study chair, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186506
- Sponsor's protocol ID
- BD-EN-IV005
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05186506
- Acronym / sponsor ID
- BD-EN-IV005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 11 Jan 2022 (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 randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection
Detailed description
Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day (QD) taken with food for 2 years. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Treatments will continue until disease recurrence, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy), or achieving a maximum treatment duration of 2 years. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensatinib | Experimental | Drug: Ensatinib225 mg administered once daily orally for two years. |
| Platinum-Based Chemotherapy | Active comparator | Drug: chemotherapyPatients in the chemotherapy group were allowed to cross into the Ensatinib treatment group after the disease progressed. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Surgical resection of histologically confirmed Stage IIA to IIIA NSCLC with negative margins, ,within 10 weeks after the operation
- Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
- At least 3-months life expectancy
- Adequate organ function
Key exclusion criteria (14 listed)
- More than 10 weeks before surgery Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Use of other investigational drug within 4 weeks prior to the first dose of Ensartinib
- Prior stem cell or organ transplant
- severe cardiovascular disease
- Presence of active gastrointestinal (GI) disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of Ensartinib
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 |
|---|---|---|
| EnsatinibAlso: X-396225 mg administered once daily orally for two years. | Drug | Ensatinib |
| chemotherapyPemetrexed : Participants will receive 500 mg/m^2, day 1 , Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Cisplatin :Participants will receive 75 mg/m^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Paclitaxel: Participants will receive 175 mg/ m^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. carboplatin AUC= 5 mg/ mL/min, intravenously guttae, day 1 ,Q21D ，until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. | Drug | Platinum-Based Chemotherapy |
Primary outcome
Disease free survival (DFS)
Time frame: From date of randomization until date of the first observation of tumor recurrence, metastasis (based on imaging ) or death, up to approximately 5 years.
4 secondary outcomes
DFS at 2 years
Time frame: Assessed at 2 years
DFS at 3 years
Time frame: Assessed at 3 years
Overall survival (OS)
Time frame: The time from the date of randomization to death from any cause, up to approximately 7 years
OS rate at 5 years
Time frame: Assessed at 5 years
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 11 Jan 2022.
- 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.
You Lu, MD study chair
Sichuan University
Meijuan Huang, MD study chair
Sichuan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensatinib and chemotherapy in people with ALK Fusion Protein Expression and Adjuvant Therapy, run by Sichuan 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 8 inclusion and 14 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 11 Jan 2022. 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 You Lu, MD (+8618980601763, radyoulu@hotmali.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: From date of randomization until date of the first observation of tumor recurrence, metastasis (based on imaging ) or death, up to approximately 5 years.). 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 11 Jan 2022; AzTrials last refreshed its copy on 26 Oct 2026.