Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05132218
Status:
RECRUITING
Last Update Posted:
2021-11-24
First Post:
2021-10-26
Brief Title:
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFLRWR
Brief Summary:
The experimental design is exploratory single-arm multi-center real-world research
Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world Ensatinib is effective for the newly treated ALK advanced NSCLC
1 Efficacy and safety
2 The relationship between molecular mechanism and curative effect
3 Ensatinib resistance mechanism
Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world Ensatinib is effective for the newly treated ALK advanced NSCLC
1 Efficacy and safety
2 The relationship between molecular mechanism and curative effect
3 Ensatinib resistance mechanism
Detailed Description:
Enrolled patients
1 stage IIIB or stage IV NSCLC
2 Each center confirmed ALK by tissue samples Abbott FISH VENTANA ALK D5F3 NGS method confirmation
3 Without any ALK-TKI treatment Study endpoint
Primary endpoint
According to the RECIST11 standard the progression-free survival PFS assessed by the investigator
Secondary endpoint
According to the RECIST11 standard the objective response rate ORR evaluated by the investigator the time to treatment failure TTF according to the RECIST11 standard the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator total Lifetime OS safety
Exploratory endpoint
The correlation between the biomarkers in blood orand tissue samples and the efficacy of Ensatinib the resistance mechanism of Ensatinib
The sample size is determined
The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes Based on the proportion of patients with both subtypes in ALK-positive patients the proportion is about 40 Based on the 20 dropout rate the plan is to include ALK without distinction 180 patients with fusion subtype statistical methods
1 stage IIIB or stage IV NSCLC
2 Each center confirmed ALK by tissue samples Abbott FISH VENTANA ALK D5F3 NGS method confirmation
3 Without any ALK-TKI treatment Study endpoint
Primary endpoint
According to the RECIST11 standard the progression-free survival PFS assessed by the investigator
Secondary endpoint
According to the RECIST11 standard the objective response rate ORR evaluated by the investigator the time to treatment failure TTF according to the RECIST11 standard the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator total Lifetime OS safety
Exploratory endpoint
The correlation between the biomarkers in blood orand tissue samples and the efficacy of Ensatinib the resistance mechanism of Ensatinib
The sample size is determined
The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes Based on the proportion of patients with both subtypes in ALK-positive patients the proportion is about 40 Based on the 20 dropout rate the plan is to include ALK without distinction 180 patients with fusion subtype statistical methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None