Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247605
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-10-09
Brief Title:
A Phase IIII Study of AL8326 in Small Cell Lung Cancer
Sponsor:
Advenchen Laboratories Nanjing Ltd
Organization:
Advenchen Laboratories LLC
Study Overview
Official Title:
Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer SCLC patients with disease progression or recurrence after receiving at least second-line treatment regimens
Detailed Description:
There are 2 treatment groups in this trial and the study population sample size and basic design of each group are
Patients with pathologically confirmed small cell lung cancer at baseline and need or 3rd line treatment the sample size was expected to be 243 cases 162 in the active group and 81 in the control group
Subjects will be randomized in a 21 ratio under double-blind conditions into two groups with the active group receiving the trial drug AL8326 tablets and the control group receiving placebo AL8326 tablets and placebo are administered as follows oral administration once daily for 28 days per cycle until intolerable toxicity or established disease progression or death or voluntary withdrawal or up to 12 months approximately 13 cycles of treatment Subjects will have a final visit followed by a long-term follow-up period and the tumor disease status will be determined according to RECIST 11
Patients with pathologically confirmed small cell lung cancer at baseline and need or 3rd line treatment the sample size was expected to be 243 cases 162 in the active group and 81 in the control group
Subjects will be randomized in a 21 ratio under double-blind conditions into two groups with the active group receiving the trial drug AL8326 tablets and the control group receiving placebo AL8326 tablets and placebo are administered as follows oral administration once daily for 28 days per cycle until intolerable toxicity or established disease progression or death or voluntary withdrawal or up to 12 months approximately 13 cycles of treatment Subjects will have a final visit followed by a long-term follow-up period and the tumor disease status will be determined according to RECIST 11
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