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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHarbin Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Cohort 1: Patients who are participating in other clinical studies outside of this research;

Trial population

ALK+

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 3 trial groups
Group A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3

Trial outcomes

Primary outcomes

1

MPR

Main pathological remission rate

Time frame
6month

Secondary outcomes

1

pCR

Pathological complete response rate

Time frame
6month
2

2-year disease-free survival rate

2-year disease-free survival rate

Time frame
2year
3

ORR

Objective response rate

Time frame
1year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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