Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738317
Status:
RECRUITING
Last Update Posted:
2023-02-22
First Post:
2023-02-12
Brief Title:
Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Non-squamous NSCLC After First-line Treatment
Sponsor:
Xiaorong Dong
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Prospective Single-arm Phase II Trial of Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Advanced Non-squamous Non-small Cell Lung Cancer After First-line Immunotherapy Progression
Status:
RECRUITING
Status Verified Date:
2023-02
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:
A prospective single-arm phase II trial of Adebrelimab combined with bevacizumab and albumin paclitaxel in advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression
Detailed Description:
The study consisted of a screening period no more than 4 weeks after patients signed informed consent until enrollment with imaging assessments allowed to be archived within 4 weeks prior to enrollment a treatment period treatment termination defined as discontinuation of treatment for any reason or withdrawal from the study for any reason a safety follow-up period and a survival follow-up period
Screening period
Patients were required to undergo a screening evaluation to determine their eligibility for the study within 4 weeks prior to enrollment
Patients eligible for the study receive adebrelimab 20 mgkg Intravenous infusion Q3W bevacizumab 75 mgkg Intravenous infusion Q3W albumin paclitaxel 100 mgm2 D1 8 15 Intravenous infusion Q3W albumin paclitaxel treatment for 4 cycles adebrelimab bevacizumab use to PD intolerable toxicity patient withdrawal of informed consent investigator decision to discontinue study treatment
Treatment period
Patients eligible for study enrollment were given medication sequentially on day 1 of each cycle with a dosing window of 5 days and patients were required to complete various examinations including vital signs height and weight physical examination laboratory tests and physical status scores to assess tolerance for continued treatment The specific examinations and requirements for each visit are shown in the study flow chart
End of treatment
End of treatment is defined as confirmation of disease progression or withdrawal from the study and requires an end-of-treatment visit 5 days from the time of the decision to discontinue treatment andor withdraw from the study
Safety follow-up Safety follow-up visits will be conducted within 307 607 days and 907 days after the last dose
Survival follow-up Survival follow-up will be conducted every 3 months after safety follow-up and telephone follow-up is acceptable
Screening period
Patients were required to undergo a screening evaluation to determine their eligibility for the study within 4 weeks prior to enrollment
Patients eligible for the study receive adebrelimab 20 mgkg Intravenous infusion Q3W bevacizumab 75 mgkg Intravenous infusion Q3W albumin paclitaxel 100 mgm2 D1 8 15 Intravenous infusion Q3W albumin paclitaxel treatment for 4 cycles adebrelimab bevacizumab use to PD intolerable toxicity patient withdrawal of informed consent investigator decision to discontinue study treatment
Treatment period
Patients eligible for study enrollment were given medication sequentially on day 1 of each cycle with a dosing window of 5 days and patients were required to complete various examinations including vital signs height and weight physical examination laboratory tests and physical status scores to assess tolerance for continued treatment The specific examinations and requirements for each visit are shown in the study flow chart
End of treatment
End of treatment is defined as confirmation of disease progression or withdrawal from the study and requires an end-of-treatment visit 5 days from the time of the decision to discontinue treatment andor withdraw from the study
Safety follow-up Safety follow-up visits will be conducted within 307 607 days and 907 days after the last dose
Survival follow-up Survival follow-up will be conducted every 3 months after safety follow-up and telephone follow-up is acceptable
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