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Nonsmall Cell Lung CancerPhase 2NCT03753685

X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

A Phase 2 study testing X-396(Ensartinib) Capsule in people with Nonsmall Cell Lung Cancer and Brain Metastases, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Nonsmall Cell Lung Cancer, Brain Metastases
What is being tested?
X-396(Ensartinib) Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
12 Apr 2019to 30 Jun 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
  • 2. 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.
  • 3. 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.
  • 4. Female or male, 18 years of age or older 5. A Karnofsky Performance Status score of at least 60. 6. An expected survival time of at least 12 weeks. 7. Adequate organ functions, defined as absolute neutrophils count ≥1.510^9/L，platelets count ≥8010^9/L, hemoglobin concentration≥ 9 g/dL, total bilirubin ≤1.5 ULN (upper limits of normal), ALT≤2.5 ULN, AST≤2.5 ULN, creatinine≤1.5 ULN.
  • 8. Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
  • 9. Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • 10. Signed and dated informed consent.

Who cannot join

  • 1. Currently under treatment of other systemic anti-cancer therapies. 2. Evidence of active malignancy within last 5 years. 3. Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
  • 4. Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment, or received radiotherapy within last 2 weeks before the initiation of study treatment.
  • 5. Patients who previously received organ transplantation or stem cell transplantation.
  • 6. Patients with clinically significant cardiovascular and cerebrovascular diseases.
  • 7. Patients with dysphagia, active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
  • 8. Patients who are active carrier of hepatitis B (HBsAg positive and HBV-DNA ≥500IU/mL), hepatitis C virus antibody, treponema pallidum antibody or HIV antibody.
Show all 11Show fewer
  • 9. Patients with interstitial lung disease history or signs of active interstitial lung disease.
  • 10. Pregnant and lactating women. 11. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
  • 12. Patients who need to receive drugs which could induce QT/QTc interval prolongation or torsade de pointes, or drugs which are potent CYP3A4 inhibitors or inducers within last 14 days before the initiation of study treatment and during the study.
  • 13. Patients who are currently under treatment of warfarin or other coumarin anticoagulants.
  • 14. Patients with other illness or medical conditions potentially interfering with the study treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong, 518100

Other trials in China

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.

Being tested
X-396(Ensartinib) Capsule
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) CapsuleDrug

    All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.

Study groups in NCT03753685
Study groupRoleWhat they receive
X-396(Ensartinib) CapsuleExperimentalNot described
Receives: Drug: X-396(Ensartinib) Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (16)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Duration of response based on intracranial response (iDOR) according to RECIST 1.1

    Defined as time from documentation of intracranial response (CR or PR) to intracranial disease progression or death, assessed by investigator.

    Measured: 36 months

  10. 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

  11. 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

  12. 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

  13. 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

  14. Duration of response based on overall response (DOR) according to RECIST 1.1

    Defined as time from documentation of overall response (CR or PR) to overall disease progression or death, assessed by investigator.

    Measured: 36 months

  15. Overall survival (OS)

    Defined as time from first dose of X-396 to death due to any causes.

    Measured: 36 months

  16. 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.

  1. First posted27 Nov 2018
  2. Study start12 Apr 2019
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753685
Sponsor's protocol ID
BTP-42324-IIT
Status last verified
Jul 2025
First submitted
22 Nov 2018
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing X-396(Ensartinib) Capsule in people with Nonsmall Cell Lung Cancer and Brain Metastases, run by Fudan University 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT03753685.

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 Jul 2025.

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