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.

NCT06736561 | Not Yet Recruiting

• 1 other identifier: 2024-275-IIT
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ALK Positive; Ensartinib; NSCLC; Neoadjuvant Therapy

Keywords

ALK Positive; Ensartinib; NSCLC; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• MPR

  Main pathological remission rate

  6month

Secondary Outcomes (3)

• pCR

  6month

• 2-year disease-free survival rate

  2year

• ORR

  1year

Study Arms (3)

Cohort 1

Data on the efficacy and safety of patients who had previously used enshatinib in the neoadjuvant phase were retrospectively collected

Cohort 2

Akl-positive patients received enshatinib monotherapy neoadjuvant therapy for 6-12 weeks

Cohort 3

Alk-positive patients received neoadjuvant therapy that included enshatinib and did not meet cohort 2 inclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALK+

You may qualify if:

• 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: 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Harbin Medical University: lead

Central Study Contacts

Ma

CONTACT

86+ 18646101888; jianqunma@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: archiater

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share