Non-small Cell Lung CancerPhase 3NCT05341583
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
A Phase 3 study testing Ensartinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Ensartinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2022to 23 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 diagnosis of primary non-small cell carcinoma of the lung.
- Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0).
- Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
- Confirmation by the central laboratory that the tumour harbours ALK positive.
- At least 1-year life expectancy.
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
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- The laboratory test values should meet the following requirements:
- Absolute neutrophil count ≥ 1.5 x 109/L , Platelets ≥ 100 x 109/L ，hemoglobin ≥9g/dL
- Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 x institutional upper limit of normal
- Creatinine≤ 1.5 x institutional upper limit of normal ,if not, Creatinine Clearance ≥ 50 ml/min
- International normalized ratio (INR) and prothrombin time ≤1.5 x institutional upper limit of normal; and activated partial thromboplastin time (aPTT) ≤1.5 x institutional upper limit of normal
- Female patients must have a negative pregnancy test at baseline.
Who cannot join
- Patients who are participating in other clinical studies or are receiving other investigational drugs , or investigational devices within 4 weeks before the first dose of our study drugs. If patients are participating in non-interventional clinical trials, they can be included in this study.
- Patients who have a presence of unresectable or metastatic disease, the pathological diagnosis show the microscopically positive surgical margins or extranodal invasion, or residual disease of surgery，or had only segmentectomies or wedge resections.
- Patients with superior sulcus cancer.
- Patients who have received a surgery with total right lung resection.
- History of other malignancies within 5 years of the first dose of the study drug, except: malignant tumors that can be expected to recover after treatment.
- Prior treatment with other anti-cancer treatments or NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
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- Major surgery within 3 weeks of the first dose of the study drug.
- Patients who have used traditional Chinese medicines and traditional Chinese medicine preparations with indications for anti-tumor therapy or adjuvant therapy for tumors within 14 days of the first dose of the study drug.
- Patients who have used the following drugs within 14 days before the first dose : strong inhibitors, strong inducers of CYP3A or CYP3A substrates with a narrow therapeutic index.
- Patients who have severe cardiovascular disease.
- Patients with a known allergy to Tartrazine，a dye used in 100mg capsules.
- Severe active infection, interstitial lung disease/pneumonitis, or any serious underlying disease that may interfere with the subject's treatment with the regimen within 2 weeks prior to the first dose of study drug.
- Active HIV virus antibody,Treponema pallidum antibody positive.
- Active hepatitis B, hepatitis C virus antibody positive, or active tuberculosis.
- Presence of active gastrointestinal (GI) disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of study drugs.
- According to the judgment of the investigator, other conditions may affect the compliance of the protocol or affect the subject's signing of the informed consent, or is not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TianJin Medical University Cancer Institute & Hospital
Tianjin
Chang Li Wang, Ph.D, 86-22-23340123 ext. 3180, wangchangli@tjmuch.com
About this study
Official title: A Phase Ⅲ, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage IB- IIIB Non-small Cell Lung Cancer.
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, multicenter, Phase III study, the primary endpoint is disease-free survival. Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day taken with or without food for 2 years. Participants in the control arm will receive placebo at 225 mg orally once a day taken with or without food for 2 years. 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, whichever occurs earlier. At the time of treatment discontinuation, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Ensartinib, Placebo
- 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
Also called X-396
Ensartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.
PlaceboDrug
Placebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.
| Study group | Role | What they receive |
|---|---|---|
| Ensatinib | Experimental | Ensatinib ( 225 mg, once daily), in accordance with the randomization schedule Receives: Drug: Ensartinib |
| Placebo | Placebo comparator | Placebo ( 225 mg, once daily), in accordance with the randomization schedule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
From date of randomization until date of tumor recurrence or death, whichever occurs earlier
Measured: up to 5 years
Secondary outcomes (4)
DFS rate at 3 years
Measured: Assessed at 3 years
DFS rate at 5 years
Measured: Assessed at 5 years
Overall survival (OS)
Measured: Assessed at 5 years
OS rate at 5 years
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start24 May 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion23 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341583
- Sponsor's protocol ID
- BTP-42338
- Status last verified
- Aug 2024
- First submitted
- 18 Apr 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yue D, Huang M, Song P, Chen Y, Li B, Fu J, Guo J, Cheng C, Chen Q, Xu S, Liu H, Lv F, Hu J, Jiang K, Mao W, Shen B, Ye F, Li J, Zhang X, Guo S, Yu B, Zhu Y, Wu M, Zheng W, Chen F, He Z, Bai Y, Xin H, Chen K, Mao N, Zhang Y, Wang B, Zhang L, Chen X, Mei X, Miao L, Wang R, Li G, Yao J, Zhao J, Chen C, Liu J, Wei L, Yan X, Jin B, Liu X, Liu Z, Tian H, Xing W, Yang L, Ge D, Li X, Li S, Song Y, Zang A, Zhang D, Zhuang W, Liu Z, Yuan X, Fu T, Shen Z, Zhang X, Cao Q, Zhao L, Mao L, Ding L, Lu Y, Wang C; ELEVATE Study Group. Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2026 Jul 9;395(2):151-161. doi: 10.1056/NEJMoa2518990.
PubMed 42418775
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage IB- IIIB Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT05341583
- Acronym / sponsor ID
- BTP-42338
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 23 Jul 2025 (estimated)
- First posted
- 22 Apr 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 double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.
Detailed description
This is a double-blind, randomized, placebo-controlled, multicenter, Phase III study, the primary endpoint is disease-free survival. Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day taken with or without food for 2 years. Participants in the control arm will receive placebo at 225 mg orally once a day taken with or without food for 2 years. 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, whichever occurs earlier. At the time of treatment discontinuation, 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensatinib | Experimental | Drug: EnsartinibEnsatinib ( 225 mg, once daily), in accordance with the randomization schedule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo ( 225 mg, once daily), in accordance with the randomization schedule |
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 diagnosis of primary non-small cell carcinoma of the lung.
- Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0).
- Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
- Confirmation by the central laboratory that the tumour harbours ALK positive.
- At least 1-year life expectancy.
Key exclusion criteria (16 listed)
- Patients who are participating in other clinical studies or are receiving other investigational drugs , or investigational devices within 4 weeks before the first dose of our study drugs. If patients are participating in non-interventional clinical trials, they can be included in this study.
- Patients who have a presence of unresectable or metastatic disease, the pathological diagnosis show the microscopically positive surgical margins or extranodal invasion, or residual disease of surgery，or had only segmentectomies or wedge resections.
- Patients with superior sulcus cancer.
- Patients who have received a surgery with total right lung resection.
- History of other malignancies within 5 years of the first dose of the study drug, except: malignant tumors that can be expected to recover after treatment.
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 |
|---|---|---|
| EnsartinibAlso: X-396Ensartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier. | Drug | Ensatinib |
| PlaceboPlacebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier. | Drug | Placebo |
Primary outcome
Disease free survival (DFS)
Time frame: up to 5 years
From date of randomization until date of tumor recurrence or death, whichever occurs earlier
4 secondary outcomes
DFS rate at 3 years
Time frame: Assessed at 3 years
DFS rate at 5 years
Time frame: Assessed at 5 years
Overall survival (OS)
Time frame: Assessed at 5 years
OS rate at 5 years
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42418775Yue D, Huang M, Song P, Chen Y, Li B, Fu J, Guo J, Cheng C, Chen Q, Xu S, Liu H, Lv F, Hu J, Jiang K, Mao W, Shen B, Ye F, Li J, Zhang X, Guo S, Yu B, Zhu Y, Wu M, Zheng W, Chen F, He Z, Bai Y, Xin H, Chen K, Mao N, Zhang Y, Wang B, Zhang L, Chen X, Mei X, Miao L, Wang R, Li G, Yao J, Zhao J, Chen C, Liu J, Wei L, Yan X, Jin B, Liu X, Liu Z, Tian H, Xing W, Yang L, Ge D, Li X, Li S, Song Y, Zang A, Zhang D, Zhuang W, Liu Z, Yuan X, Fu T, Shen Z, Zhang X, Cao Q, Zhao L, Mao L, Ding L, Lu Y, Wang C; ELEVATE Study Group. Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2026 Jul 9;395(2):151-161. doi: 10.1056/NEJMoa2518990.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ensartinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. 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 16 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Li Wang, Ph.D (86-22-23340123 ext. 3180, wangchangli@tjmuch.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: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341583, which also lists 1 linked publication.
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 23 Aug 2024.