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.

NCT ID: NCT06736561

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Cohort 1

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

No interventions assigned to this group

Cohort 2

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

No interventions assigned to this group

Cohort 3

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

No interventions assigned to this group

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianqun Ma

archiater

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ma

Role: CONTACT

Phone: 86+ 18646101888

Email: jianqunma@aliyun.com

Other Identifiers

2024-275-IIT

Identifier Type: -

Identifier Source: org_study_id