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NCT Number: NCT06736561

A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.

Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cohort 1: Female or male aged >=18 years;
  • Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;
  • Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
  • Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.
  • Cohort 2: Female or male aged >=18 years;
  • Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;
  • Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
  • Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
  • Cohort 2: Signed informed consent form;
  • Cohort 3: Female or male aged >=18 years;
  • Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;
  • Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;
  • Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
  • Cohort 3: Signed informed consent form.

Exclusion criteria

  • Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
  • Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
  • Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
  • Cohort 1: Patients who are participating in other clinical studies outside of this research;
  • Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
  • Cohort 2: Patients who have received Ensartinib treatment before the study started;
  • Cohort 2: Patients who have received other systemic treatments besides Ensartinib;
  • Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;
  • Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
  • Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
  • Cohort 2: Patients who are participating in other clinical studies outside of this research;
  • Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.
  • Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;
  • Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
  • Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
  • Cohort 3: Patients who are participating in other clinical studies outside of this research;
  • Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.

Treatment and study plan

Primary outcomes

  1. MPR

    Time frame: 6month

    Main pathological remission rate

Secondary outcomes

  1. pCR

    Time frame: 6month

    Pathological complete response rate

  2. 2-year disease-free survival rate

    Time frame: 2year

    2-year disease-free survival rate

  3. ORR

    Time frame: 1year

    Objective response rate

Study contacts

Contact information is provided by the study sponsor or research team.

Ma

CONTACT

[email protected]

86+ 18646101888

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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