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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
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.
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 mg/kg, Intravenous infusion, Q3W + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W + albumin paclitaxel 100 mg/m2, 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 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Union hospital
Wuhan, Hubei, China
Start Date
December 1, 2022
Primary Completion Date
June 1, 2023
Completion Date
December 1, 2024
Last Updated
February 22, 2023
45
ESTIMATED participants
Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel
DRUG
Lead Sponsor
Xiaorong Dong
NCT06305754
NCT07190248
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100080