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EFLRWR: Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05132218
Collaborator
Betta Pharmaceuticals Co., Ltd. (Industry)
180
Enrollment
1
Location
36.4
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The experimental design is exploratory, single-arm, multi-center, real-world research.

Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC

  1. Efficacy and safety;

  2. The relationship between molecular mechanism and curative effect;

  3. Ensatinib resistance mechanism;

Condition or Disease Intervention/Treatment Phase

Detailed Description

Enrolled patients:

  1. stage IIIB or stage IV NSCLC

  2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);

  3. Without any ALK-TKI treatment; Study endpoint

Primary endpoint:

According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;

Secondary endpoint:

According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;

Exploratory endpoint:

The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;

The sample size is determined:

The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:

Study Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Actual Study Start Date :
Oct 19, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer

Ensatinib 225mg QD Until the disease progresses or intolerance

Drug: Ensatinib
Prospective, exploratory, single-arm, multi-center, real-world research
Other Names:
  • BD-EN-IV002

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [2021.09.27-2024.12.30]

    Secondary Outcome Measures

    1. overall survival [2021.09.27-2024.12.30]

    2. Time-to-TreatmentFailure [2021.09.27-2024.12.30]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. stage IIIB or stage IV NSCLC by histology or cytology;

    2. All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);

    3. Without any ALK-TKI treatment;

    4. Voluntarily and capable of following the trial and follow-up procedures;

    5. Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.

    Exclusion Criteria:
      1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.

    Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg).

    1. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.

    2. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing Beijing China 100176

    Sponsors and Collaborators

    • Peking University Cancer Hospital & Institute
    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Zhao, Professor, Peking University Cancer Hospital & Institute
    ClinicalTrials.gov Identifier:
    NCT05132218
    Other Study ID Numbers:
    • BD-EN-IV002
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Nov 24, 2021