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Non Small Cell Lung CancerPhase 2NCT05380024

A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer

A Phase 2 study testing Ensartinib in people with Non Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a Phase II, single-Arm, prospective study of neoadjuvant Ensartinib for the treatment of patients with ALK positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Ensartinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesChina
Study dates
17 Aug 2022to 30 Jun 2024
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • Male or female, at least 18 years of age.
  • Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.
  • Clinical stage IIA/IIB/IIIA/IIIB assessed by EBUS-TBNA or PET(positron emission tomography)/CT can be resected.
  • Patients confirmed as ALK positive (FISH or Ventana IHC or RT-PCR, NGS)
  • Presence of at least one accurately measurable lesion, CT showing a maximum diameter of 10mm at baseline (except for lymph nodes with a short axis of 15mm required) and suitable for accurate repeat measurements.
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  • Eastern Cooperative Oncology Group (ECOG) performance status （PS） of 0 or 1 at enrolment.
  • Hematology , liver and kidney function are adequate for neoadjuvant therapy.
  • Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis).
  • Serum pregnancy test (for females of childbearing potential) negative at screening.Female patients of non-childbearing potential must meet at least 1 of the following criteria:
  • ① Achieved postmenopausal status, defined as follows: cessation of regular menses forat least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle- stimulating hormone (FSH)level confirming the postmenopausal state;
  • ② Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • ③ Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations） are considered to be of childbearing potential.
  • Male subjects must be willing to use barrier contraception

Who cannot join

  • Mixed squamous cell carcinoma, large cell carcinoma，small cell lung cancer.
  • Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
  • Pregnant female patients; breastfeeding female patients.
  • Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of Cytochrome P450 3A4(CYP3A4)(at least 3 weeks prior).
  • Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (e.g., in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Past medical history of Interstitial lung disease（ ILD）, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
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  • A history of hypersensitivity to Icotinib with or without active excipients or to drugs of similar chemical structure or class, and uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated drugs, or having undergone major bowel resection that would interfere with adequate absorption of Ensartinib.
  • Any of the following cardiac criteria:
  • ①Mean resting corrected QT interval (QTc)>470 msec, obtained from 3 electrocardiograms (ECGs)
  • ②Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec, symptomatic bradycardia <45 beats/minute.
  • ③Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
  • A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
  • Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

2 sites in 1 country.

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Nan Wu, Dr., +86-13910154426, nanwu@bjmu.edu.cn

    Recruiting

  • NAN Wu

    Beijing, Beijing Municipality, 100142

    NAN Wu, M.D., 8613466692698, nanwu@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

This is a Phase II, single-Arm, prospective study of neoadjuvant Ensartinib for the treatment of patients with ALK positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

Being tested
Ensartinib
Keywords
Resectable, NSCLC, ALK-TKI, Ensartinb, Neoadjuvant
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

    Ensartinib 225mg QD 8 weeks

Study groups in NCT05380024
Study groupRoleWhat they receive
EnsaritinibExperimentalNot described
Receives: Drug: Ensartinib

What is being measured

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

  1. Major Pathological Response (MPR)

    Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery

    Measured: From date of randomization to an average of 12 weeks after the first dose

Secondary outcomes (5)

  1. Pathological complete response (pCR)

    Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

    Measured: From date of randomization to an average of 12 weeks after the first dose

  2. Objective response rate(ORR)

    ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.

    Measured: Baseline (Prior to surgery)

  3. Disease free survival (DFS)

    DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.

    Measured: From date of randomization up to approximately 42 months after date of resection

  4. Overall Survival (OS）

    Defined as the time from the date of entry to the date of death from any cause.

    Measured: Up to approximately 5.5 years after the last patient is randomized

  5. Incidence of Adverse Events

    AE captured by CYCAE 5.0

    Measured: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start17 Aug 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05380024
Sponsor's protocol ID
BD-EN-IV0012
Status last verified
Aug 2022
First submitted
13 May 2022
Last updated
18 Aug 2022
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 Ensartinib in people with Non Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 2 sites 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 14 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response (MPR) (time frame: From date of randomization to an average of 12 weeks after the first dose). 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 NCT05380024.

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 18 Aug 2022.

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