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.

Not yet recruiting

• Conditions: ALK Positive; Ensartinib; NSCLC; Neoadjuvant Therapy

• Registration Number: NCT06736561
• Lead Sponsor: Harbin Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2025-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MPR	6month	Main pathological remission rate

Secondary Outcome Measures

Name	Time	Method
pCR	6month	Pathological complete response rate
2-year disease-free survival rate	2year	2-year disease-free survival rate
ORR	1year	Objective response rate