Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-31 @ 4:09 PM
Study NCT ID:
NCT04890795
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2021-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib / IIA Study of AL8326 in Small Cell Lung Cancer
Sponsor:
Advenchen Laboratories Nanjing Ltd.
Organization:
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 treatment,Evaluation 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 (SCLC).Three 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:
False
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?: