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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC; Neoadjuvant Therapy; ALK Positive; Ensartinib

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ma; Phone Number: 86+ 18646101888; Email: jianqunma@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ALK+

Description

Inclusion Criteria:

1. Cohort 1: Female or male aged >=18 years;
2. Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;
3. Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
4. 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.
5. Cohort 2: Female or male aged >=18 years;
6. Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;
7. Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
8. 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;
9. Cohort 2: Signed informed consent form;
10. Cohort 3: Female or male aged >=18 years;
11. Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;
12. Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;
13. 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;
14. Cohort 3: Signed informed consent form.

Exclusion Criteria:

1. Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
2. 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;
3. Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
4. Cohort 1: Patients who are participating in other clinical studies outside of this research;
5. Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
6. Cohort 2: Patients who have received Ensartinib treatment before the study started;
7. Cohort 2: Patients who have received other systemic treatments besides Ensartinib;
8. Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;
9. 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;
10. Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
11. Cohort 2: Patients who are participating in other clinical studies outside of this research;
12. Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.
13. Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;
14. 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;
15. Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
16. Cohort 3: Patients who are participating in other clinical studies outside of this research;
17. Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPR	Main pathological remission rate	6month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	Pathological complete response rate	6month
2-year disease-free survival rate	2-year disease-free survival rate	2year
ORR	Objective response rate	1year

Collaborators and Investigators

• Sponsor: Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Neoadjuvant therapy; Ensartinib; ALK Positive
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2024-275-IIT

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