The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors

January 10, 2025 updated by: Chunxia Su, Shanghai Pulmonary Hospital, Shanghai, China
This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 40 patients will be enrolled in the study. All patients will receive adjuvant therapy with Ensartinib at a dose of 200 mg, once daily, orally, for a continuous period of 2 years, or until disease recurrence or intolerable toxicity occurs. The efficacy and safety of Ensartinib treatment will be evaluated.Before any study-related procedures are conducted, informed consent will be obtained. Demographic information, a complete medical history, surgical history, and smoking history will be collected. The TNM stage of the primary tumor at diagnosis will be recorded/confirmed. Tumor assessments and other screening examinations required for the screening period will be completed.Ensartinib will be administered at a dose of 200 mg, orally, once daily, for 2 consecutive years. During the first year, efficacy evaluations and safety visits (including physical examinations, laboratory tests, tumor assessments, and quality-of-life assessments) will be conducted every 12 weeks. During the second year and beyond (prior to progression), efficacy evaluations and safety visits will be conducted every 24 weeks.After the study completion by the investigator and the recording of disease progression at each stage, long-term survival follow-up information will be collected every 24 weeks. Patients who discontinue study treatment for reasons other than disease progression (excluding loss to follow-up or death) will continue to undergo objective tumor assessments every 24 weeks to gather information on disease progression. If a patient experiences recurrence within 2 years post-surgery, survival follow-up will be conducted via telephone every 24 weeks after recurrence, continuing until 5 years post-surgery or death.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-75 years;
  • ECOG performance status 0-1;
  • Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;
  • Confirmed ALK fusion-positive by FISH, IHC, or NGS;
  • No prior systemic treatment after surgery;
  • At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;
  • Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;
  • Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g/L; Absolute neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL/min;
  • Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;
  • Informed consent obtained from the patient or their legal representative;
  • Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.

Exclusion Criteria:

  • Previous systemic treatment for NSCLC;
  • Previous local radiotherapy for NSCLC;
  • Unable to take oral medications;
  • Known allergy to Ensartinib or any component of this product;
  • History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;
  • Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;
  • Pregnant or breastfeeding women;
  • History of definite neurological or psychiatric disorders, including epilepsy or dementia;
  • Any other conditions that the investigator deems unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.
Drug: Ensartinib group
Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
2 year disease-free survival rate
Time Frame: up to 2 year
2-year DFS rate refers to the percentage of patients who remain free of any signs or symptoms of the disease (in this case, cancer) for two years after receiving treatment.
up to 2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
5 year overall survival rate.
Time Frame: up to 5 year
The 5 year overall survival rate (5-year OS) is a critical measure in clinical oncology, indicating the percentage of patients who are still alive five years after being diagnosed with cancer or starting treatment.
up to 5 year
Disease-free survival
Time Frame: up to 5 year
Disease-free survival (DFS) is a measure used in clinical oncology to describe the length of time after treatment during which a patient remains free from any signs or symptoms of the disease.
up to 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024LY1286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings