Clinical trial NCT06736561: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ALK Positive
Ensartinib
NSCLC
Neoadjuvant Therapy
Keywords: ALK Positive
Ensartinib
NSCLC
Neoadjuvant therapy
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALK+

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.


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.

Primary outcomes:
measure: MPR
timeFrame: 6month
Secondary outcomes:
measure: pCR
timeFrame: 6month
measure: 2-year disease-free survival rate
timeFrame: 2year
measure: ORR
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
References: