Lung Cancer, Nonsmall CellPhase 2NCT04415320
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
A Phase 2 study testing X-396(Ensartinib) in people with Lung Cancer, Nonsmall Cell and Brain Metastases, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Brain Metastases
- What is being tested?
- X-396(Ensartinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2019to Jun 2021
- Phase
- Phase 2
- 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
- Female or male, 18 years of age or older
- Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
- Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
- At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
- A Karnofsky Performance Status score of at least 60.
- An expected survival time of at least 12 weeks.
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- Adequate organ functions.
- Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
- Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Signed and dated informed consent.
Who cannot join
- Currently under treatment of other systemic anti-cancer therapies.
- Evidence of active malignancy within last 5 years.
- Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
- Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment.
- Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study.
- Patients who previously received organ transplantation or stem cell transplantation.
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- Patients with clinically significant cardiovascular diseases.
- Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
- Patients with interstitial lung disease history or signs of active interstitial lung disease.
- Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
- Pregnant and lactating women.
- Patients with other illness or medical conditions potentially interfering with the study treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Jianhua Chang, 8613916619284, changjianhua@163.com
About this study
Official title: Efficacy and Safety of X-396 (Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
Read the detailed description
In this phase Ⅱ, open-label, single arm, multicenter study, efficacy and safety of oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed. Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology (RANO) are primary outcome measures.
- Conditions
- Lung Cancer, Nonsmall Cell, Brain Metastases
- Being tested
- X-396(Ensartinib)
- Keywords
- NSCLC, Brain metastases, ALK mutations, X-396 (Ensartinib)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-396(Ensartinib)Drug
All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| X-396(Ensartinib) Capsule | Experimental | Not described Receives: Drug: X-396(Ensartinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.
iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.
Measured: 12 weeks
Secondary outcomes (14)
Disease control rate based on intracranial response (iDCR) according to RANO-BM.
Defined as the percentage of patients who have achieved intracranial overall response of CR, PR and stable disease (SD), assessed by investigator.
Measured: 12 weeks
Progression-free survival based on intracranial response (iPFS) according to RANO-BM
Defined as time from first dose of X-396 capsule to intracranial disease progression or death due to any causes, assessed by investigator.
Measured: 36 months
Time to progression based on intracranial response (iTTP) according to RANO-BM.
Defined as time from first dose of X-396 capsule to intracranial disease progression, assessed by investigator.
Measured: 36 months
Duration of response based on intracranial response (iDOR) according to RANO-BM.
Defined as time from documentation of intracranial response (CR or PR) to intracranial disease progression or death, assessed by investigator.
Measured: 36 months
Intracranial objective response rate (iORR) based on intracranial response according to RECIST 1.1.
iORR per RECIST 1.1 calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.
Measured: 12 weeks
Disease control rate based on intracranial response (iDCR) according to RECIST 1.1
Defined as the percentage of patients who have achieved intracranial overall response of CR, PR and stable disease (SD), assessed by investigator.
Measured: 12 weeks
Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1
Defined as time from first dose of X-396 capsule to intracranial disease progression or death due to any causes, assessed by investigator.
Measured: 36 months
Time to progression based on intracranial response (iTTP) according to RECIST 1.1
Defined as time from first dose of X-396 capsule to intracranial disease progression, assessed by investigator.
Measured: 36 months
Objective response rate (ORR) based on overall response according to RECIST 1.1.
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.
Measured: 12 weeks
Disease control rate based on overall response (DCR) according to RECIST 1.1
Defined as the percentage of patients who have achieved overall response of CR, PR and stable disease (SD), assessed by investigator.
Measured: 12 weeks
Progression-free survival based on overall response (PFS) according to RECIST 1.1
Defined as time from first dose of X-396 capsule to overall disease progression or death due to any causes, assessed by investigator.
Measured: 36 months
Time to progression based on overall response (TTP) according to RECIST 1.1
Defined as time from first dose of X-396 capsule to overall disease progression, assessed by investigator.
Measured: 36 months
Overall survival (OS)
Defined as time from first dose of X-396 to death due to any causes.
Measured: 36 months
Incidence of patients experiencing adverse events.
Incidence of adverse events occurred during the study (from the timeoint of signing a informed consent form to 30days after the end of trial) .
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Mar 2019
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415320
- Sponsor's protocol ID
- BTP-42324-IIT
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of X-396 (Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT04415320
- Acronym / sponsor ID
- BTP-42324-IIT
- Conditions
- Lung Cancer, Nonsmall Cell, Brain Metastases
- Keywords
- NSCLC, Brain metastases, ALK mutations, X-396 (Ensartinib)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
Detailed description
In this phase Ⅱ, open-label, single arm, multicenter study, efficacy and safety of oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed. Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology (RANO) are primary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-396(Ensartinib) Capsule | Experimental | Drug: X-396(Ensartinib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or male, 18 years of age or older
- Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
- Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
- At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
- A Karnofsky Performance Status score of at least 60.
Key exclusion criteria (12 listed)
- Currently under treatment of other systemic anti-cancer therapies.
- Evidence of active malignancy within last 5 years.
- Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
- Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment.
- Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study.
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 |
|---|---|---|
| X-396(Ensartinib)All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily. | Drug | X-396(Ensartinib) Capsule |
Primary outcome
Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.
Time frame: 12 weeks
iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.
14 secondary outcomes
Disease control rate based on intracranial response (iDCR) according to RANO-BM.
Time frame: 12 weeks
Progression-free survival based on intracranial response (iPFS) according to RANO-BM
Time frame: 36 months
Time to progression based on intracranial response (iTTP) according to RANO-BM.
Time frame: 36 months
Duration of response based on intracranial response (iDOR) according to RANO-BM.
Time frame: 36 months
Intracranial objective response rate (iORR) based on intracranial response according to RECIST 1.1.
Time frame: 12 weeks
Disease control rate based on intracranial response (iDCR) according to RECIST 1.1
Time frame: 12 weeks
Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1
Time frame: 36 months
Time to progression based on intracranial response (iTTP) according to RECIST 1.1
Time frame: 36 months
Objective response rate (ORR) based on overall response according to RECIST 1.1.
Time frame: 12 weeks
Disease control rate based on overall response (DCR) according to RECIST 1.1
Time frame: 12 weeks
Progression-free survival based on overall response (PFS) according to RECIST 1.1
Time frame: 36 months
Time to progression based on overall response (TTP) according to RECIST 1.1
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Incidence of patients experiencing adverse events.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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 2 study testing X-396(Ensartinib) in people with Lung Cancer, Nonsmall Cell and Brain Metastases, 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 10 inclusion and 12 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 4 Jun 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Chang (8613916619284, changjianhua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM. (time frame: 12 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 4 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.