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.

Korábbi kezelés

• Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
• 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;
• Cohort 2: Patients who have received Ensartinib treatment before the study started;
• Cohort 2: Patients who have received other systemic treatments besides Ensartinib;
• 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;
• Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;
• 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;

Más betegség

• Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
• Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
• Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;

Egyéb

• Cohort 1: Patients who are participating in other clinical studies outside of this research;
• Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
• Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;
• Cohort 2: Patients who are participating in other clinical studies outside of this research;
• Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.
• Cohort 3: Patients who are participating in other clinical studies outside of this research;
• Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.

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