Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT06736561
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;
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06736561
Study Brief:
Protocol Section:
NCT06736561