An observational study in ALK Positive, Ensartinib and NSCLC, sponsored by Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Harbin Medical University · Observational
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.
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's planned enrollment of 100 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ALK+
Exclusion Criteria:
Data on the efficacy and safety of patients who had previously used enshatinib in the neoadjuvant phase were retrospectively collected
Akl-positive patients received enshatinib monotherapy neoadjuvant therapy for 6-12 weeks
Alk-positive patients received neoadjuvant therapy that included enshatinib and did not meet cohort 2 inclusion criteria
MPR
Main pathological remission rate
Time frame: 6month
pCR
Pathological complete response rate
Time frame: 6month
2-year disease-free survival rate
2-year disease-free survival rate
Time frame: 2year
ORR
Objective response rate
Time frame: 1year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Harbin Medical University