A Phase 2 interventional study of Adebrelimab + Apatinib in Unresectable Locally Advanced Non-small Cell Lung Cancer, sponsored by Wei Zhou. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Wei Zhou · Phase 2, Interventional, and Treatment
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy.At least 32 participants will be enrolled in this study.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 32 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Wei Zhou is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All toxic effects from previous antineoplastic therapy, except hearing loss, alopecia, and fatigue, had to have recovered to grade 1 or less (according to NCI CTCAE V5.0) or baseline levels to be eligible.
Exclusion Criteria:
Patients with grade 0-1 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 42 days after definitive chemoradiotherapy
Drug: Adebrelimab + Apatinib
Patients with grade 2 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 56 days after definitive chemoradiotherapy
Drug: Adebrelimab + Apatinib
Adebrelimab combined with apatinib
Also known as: immunotherapy, Programmed death ligand 1 inhibitor, Antiangiogenic agents
Progression free survival (PFS)
Refers to the time from the start of nonrandomization until tumor progression or death from any cause, whichever occurs first
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
overall survival, OS
Refers to the time from the start of nonrandomization until death from any cause.
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Objective Response Rate, ORR
Refers to the proportion of patients who have achieved a pre-defined tumor volume reduction (CR/PR) and maintained the minimum time frame required by the accepted response evaluation criteria (such as solid tumor RECIST Version 1.1).
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Disease control rate, DCR
Proportion of all subjects whose best overall response (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria.
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Duration of response, DOR
Defined as the period from the date the tumor remission was first recorded to the date the disease progression was first recorded or the date of death from any cause
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Plan to share: Yes — The survival data of individual participant will be shared after the research iscompleted.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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