Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890795
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2021-04-26
Brief Title:
A Phase Ib IIA Study of AL8326 in Small Cell Lung Cancer
Sponsor:
Advenchen Laboratories Nanjing Ltd
Organization:
Advenchen Laboratories LLC
Study Overview
Official Title:
A Single Arm Open Non Randomized Phase Ib IIA Study to Evaluate the Safety and Preliminary Efficacy of AL8326 in the Treatment of Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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:
Based on indicators such as 24 week progression free survival 24 weeks PFS in small cell lung cancer SCLC patients without disease progression after first-line platinum containing chemotherapy objective response rate ORR in SCLC patients with recurrence or progression after first-line platinum containing chemotherapy and orr in SCLC patients with recurrence or progression after second-line and above treatmentEvaluation of the effectiveness of al8326 monotherapy in small cell lung cancer
Detailed Description:
This trial is a multicenter single arm open label nonrandomized phase Ib IIA trial that will evaluate the preliminary efficacy and safety of AL8326 in patients with small cell lung cancer SCLCThree treatment groups were used in this trial and the study population sample size and basic design of each group were as follows
Group A Patients with small-cell lung cancer without disease progression in remission PR or Cr or stable disease SD status after first-line platinum containing chemotherapy were included with a total sample size expected to be 79 patients
Group B Patients who relapsed or progressed after first-line platinum containing chemotherapy regimens with a total sample size expected to be 79 patients
Group C Patients with small cell lung cancer who have relapsed or progressed after at least one line of treatment including first-line platinum containing therapy second-line single agent or other with a total sample size expected to be 79 patients
Group A Patients with small-cell lung cancer without disease progression in remission PR or Cr or stable disease SD status after first-line platinum containing chemotherapy were included with a total sample size expected to be 79 patients
Group B Patients who relapsed or progressed after first-line platinum containing chemotherapy regimens with a total sample size expected to be 79 patients
Group C Patients with small cell lung cancer who have relapsed or progressed after at least one line of treatment including first-line platinum containing therapy second-line single agent or other with a total sample size expected to be 79 patients
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