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Lung CancerPhase 2NCT03608007

X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement

A Phase 2 study testing X-396 Capsule in people with Lung Cancer and ROS1 Gene Rearrangement, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1) positive gene mutation (translocation or inversion). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, ROS1 Gene Rearrangement
What is being tested?
X-396 Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
15 Jun 2018to Sep 2020
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 proven diagnosis of NSCLC that is locally advanced or metastatic
  • Positive for translocation or inversion events involving the ROS1 gene
  • Tyrosine kinase inhibitor (TKI) treatment-naive or have previously received no more than one systemic treatment regimen(s) such as chemotherapy (After a 3-week washout period)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Predicted survival ≥ 3 months
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  • Drug related toxicities were relieved to grade 1, except for hair loss (based on NCI CTCAE v4.03)
  • Adequate organ function
  • At least 1 measurable tumor lesion as per RECIST v1.1
  • Asymptomatic central nervous system (CNS) metastases do not require the use of steroids or anticonvulsants.
  • Signed and dated informed consent
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment

Who cannot join

  • Current treatment on another systemic anti-cancer therapy
  • Prior therapy specifically directed against ROS1 fusion genes (except for the exploratory arm that will enroll patients pretreated with crizotinib)
  • Evidence of active malignancy within last 3 years
  • Previous therapeutic clinical trial must have completed at least 4 week prior to initiation of study drug
  • Prior surgery or immunotherapy must have completed at least 4 weeks, and radiation must have been completed at least 2 weeks prior to initiation of study drug
  • Known interstitial fibrosis or interstitial lung disease
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  • Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medication
  • Clinically significant cardiovascular disease
  • Patients with a known allergy or delayed hypersensitivity reaction to study drug or its excipient
  • Pregnant or breast feeding
  • Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
  • Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
  • Other serious illness or medical condition potentially interfering with the study

Trial locations and contacts

1 site in 1 country.

Jinxiao Xu contact

86-18610155290

jinxiao.xu@bettapharma.com

China1 site, 1 recruiting

  • Chest hospital affiliated to Shanghai jiao tong university

    Shanghai, Shanghai Municipality, 200000

    Shun Lu

    Shun Lu, Ph.D

    Recruiting

Other trials in China

About this study

Official title: Phase II, Open-Label, Single Arm Study of the Efficacy and Safety of X-396 Capsule in Patients With ROS1 Positive Advanced NSCLC

To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1) positive gene mutation (translocation or inversion).

Read the detailed description

This is a phase II, multicenter, single-arm study in which the efficacy and safety of X-396 capsule (Ensartinib) will be assessed in adult Chinese patients with ROS1-positive (rearrangement or inversion) non-small cell lung cancer (NSCLC). Approximately 69 patients (59 for never-treated, and 10 for previously treated with crizotinib) with locally advanced or metastatic NSCLC carrying ROS1-rearrangement will be enrolled in the study.

Being tested
X-396 Capsule
Keywords
ROS1 NSCLC, X-396
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X-396 CapsuleDrug

    Also called Ensartinib

    225 mg once daily

Study groups in NCT03608007
Study groupRoleWhat they receive
X-396 CapsuleExperimentalSingle-arm trial whereby all consented, enrolled, eligible patients receive X-396 capsule, 225 mg once daily.
Receives: Drug: X-396 Capsule

What is being measured

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

  1. Objective response rate (ORR) based on independent radiology review (IRC) 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 IRC.

    Measured: 12 weeks

Secondary outcomes (9)

  1. ORR based on investigator assessment according to RECIST 1.1

    ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as CR or PR, based on investigator's assessment

    Measured: 12 weeks

  2. Disease control rate (DCR) according to RECIST 1.1

    DCR defined as the percentage of patients who have achieved CR, PR and stable disease (SD), based on RECIST 1.1 measured by IRC or investigator

    Measured: 12 weeks

  3. Intracranial overall response rate (iORR) by IRC and investigator assessment according to RECIST 1.1

    iORR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measurable disease in the brain at baseline.

    Measured: 12 weeks

  4. Progression-free survival (PFS) based on IRC or investigator according to RECIST 1.1

    PFS defined as time from first dose of X-396 capsule to disease progression or death due to any cause, based on RECIST 1.1.

    Measured: 36 months

  5. Time to progression (TTP) based on IRC or investigator according to RECIST 1.1

    TTP defined as time from first dose of X-396 capsule to disease progression, based on RECIST 1.1.

    Measured: 36 months

  6. Duration of response (DOR) based on IRC or investigator according to RECIST 1.1

    DOR defined as time from documentation of tumor response (CR or PR) to disease progression or death, based on RECIST 1.1

    Measured: 36 months

  7. Overall survival (OS)

    OS, defined as time from first dose of X-396 to death due to any cause.

    Measured: 36 months

  8. Change From Baseline Scores on the functional assessment of cancer therapy - Lung (FACT-L) quality of life questionnaire

    The FACT-L questionnaire consisted of several major aspects of life (Physical, social/family, emotional, and functional well-being) as well as lung cancer subscale (symptoms, cognitive function, regret of smoking). Scores for item ranging from 0 (not at all) to 4 (very much).

    Measured: 36 months

  9. Incidence of patients experiencing adverse events (AE)

    Adverse events are graded according to CTCAE 4.03

    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 posted31 Jul 2018
  2. Study start15 Jun 2018
  3. Primary completionMar 2020 (estimated)
  4. Study completionSep 2020 (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
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608007
Sponsor's protocol ID
BTP-42723
Status last verified
Dec 2019
First submitted
16 May 2018
Last updated
9 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing X-396 Capsule in people with Lung Cancer and ROS1 Gene Rearrangement, 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 13 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: status not confirmed, as of the sponsor's last update on 9 Jan 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 Jinxiao Xu (86-18610155290, jinxiao.xu@bettapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) based on independent radiology review (IRC) according to RECIST 1.1 (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 NCT03608007.

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 9 Jan 2020.

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