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Apatinib and Fluzoparib With or Without Adebrelimab in Previously-treated TP53-mutant Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:
A Phase II Study of Efficacy and Safety of Combination of Apatinib and Fluzoparib With or Without Adebrelimab in Previously-treated TP53-mutant Advanced Non-small Cell Lung Cancer

Clinical Trial Summary

This is a phase 2, open-label study to evaluate the efficacy and safety of combination of Apatinib and Fluzoparib with or without Adebrelimab in previously-treated TP53-mutant advanced non-small cell lung cancer.

Clinical Trial Description

This study is an open-label, prospective phase II study to evaluate the efficacy and safety of of combination of Apatinib and Fluzoparib with or without Adebrelimab in previously-treated TP53-mutant advanced non-small cell lung cancer. The study is divided into 2 cohorts. Cohort 1 is a two-drug cohort [Apatinib 375 mg po qd; Fluzoparib 100mg po bid], and cohort 2 is a three-drug cohort [apatinib 375 mg po qd; fluzoparib 100mg po bid; Adebrelimab 1200mg, iv, d1, q3w]. The sample sizes of these two cohorts were determined according to Simon's Two-Stage Design, and enrollment of cohort 2 will be initiated after the enrollment of cohort 1 is completed. Ultimately, 34 patients are enrolled in the cohort 1 and 26 in the cohort 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05932264
Study type Interventional
Source Sun Yat-sen University
Contact Wenfeng Fang, MD
Phone 86-20-87343894
Email fangwf@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date July 2023
Completion date December 2025
View Details
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