non-small cell lung cancer
Conditions
Interventions
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate;Overall survival;Safety;Pathological complete response rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactJianqun Ma
Harbin Medical University Cancer Hospital
Outcome results
None listed