Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT06182800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Organization:
Study Overview
Official Title:
A Prospective Study of Adebrelimab Combined With Bevacizumab and Docetaxel in the Treatment of Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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 study is a prospective, single-arm, multicenter, phase II clinical study to observe and evaluate the efficacy and safety of adebrelimab in combination with bevacizumab and docetaxel in patients with advanced non-squamous NSCLC after progression on first-line immunotherapy.
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, 1200 mg, Intravenous infusion, every 3 weeks (Q3W) + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W +docetaxel 60-75 mg/m2, D1, Intravenous infusion, Q3W. docetaxel for 4 cycles, adebrelimab, bevacizumab use to progressive disease (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 and/or withdraw from the study.
Safety follow-up. Safety follow-up visits will be conducted within 30±7, 60±7 days, and 90±7 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, 1200 mg, Intravenous infusion, every 3 weeks (Q3W) + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W +docetaxel 60-75 mg/m2, D1, Intravenous infusion, Q3W. docetaxel for 4 cycles, adebrelimab, bevacizumab use to progressive disease (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 and/or withdraw from the study.
Safety follow-up. Safety follow-up visits will be conducted within 30±7, 60±7 days, and 90±7 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:
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?: