Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05178511
Status:
RECRUITING
Last Update Posted:
2022-01-05
First Post:
2021-12-02
Brief Title:
Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance
Sponsor:
Li Zhang MD
Organization:
Sun Yat-sen University
Study Overview
Official Title:
a Prospective Open Phase ii Clinical Study in Patients With alK-positive Non-small Cell Lung Cancer Treated With Ensatinib After Second-generation ALK-TKI Resistance
Status:
RECRUITING
Status Verified Date:
2022-01
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:
ERSGATR
Brief Summary:
After the use of second-generation ALK-TKI drug resistance about 50 of tissue biopsies showed mutations in the ALK kinase domain and appropriate ALK-TKI could be selected according to different mutation sites Phase III clinical trials in the US of ensatinib showed ORR of 25 416 in patients previously treated with crizotinib and second-generation ALK-TKI N16 In the phase II registered clinical study in China biomarker analysis also showed that the ORR of ensatinib against drug resistance site G1202R was 33 26The ORR of I1171 and F1174 were 50 24 and 71 57 respectively suggesting that ensatinib may still be effective in patients with drug resistance to other second-generation ALK inhibitors Investigators designed this study to evaluate the clinical efficacy of ensatinib after second-generation ALK-TKI resistanceThe study was a single-arm multi-center Phase II clinical study using ORR of patients with measurable lesions as the primary endpoint and using Simon two-stage design to estimate the required sample sizeAt a 5 level of significance and 85 confidence a minimum of 40 evaluable subjects were required for both phasesIn the first stage 20 patients were enrolled If 2 patients had objective response an additional 20 patients were enrolled in the second stage If more than 5 patients 40 patients had objective response the therapeutic drugs were considered effectiveEligible patients will take 225mg of ensaritinib orally once daily on an empty stomach or with food until the patient develops disease progression develops unacceptable toxicity the investigator or subject decides to drop out loses follow-up starts another antitumor therapy or diesThe primary end points were objective response rate ORR to disease progression occurrence of unacceptable toxicity investigator or subject decision to drop out loss of follow-up initiation of other antitumor therapy or death
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None