Spots Global Cancer Trial Database for Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.
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Trial Identification
Brief Title: Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.
Official Title: A Phase II Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced Non-Small Cell Lung Cancer(NSCLC).
Study ID: NCT05068427
Conditions
Study Description
Brief Summary: This study is to evaluate the preliminary efficacy and safety of Chidamide combined with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC.
Detailed Description: This study including two phases: (1) Pre-test Phase, 3\~6 patients will be enrolled and receive 20 mg Chidamide BIW and 400 mg Envafolimab Q4W. The main object of pre-test phase is to evaluate the preliminary safety and tolerability of Chidamide when in combination with Envafolimab. (2) Formal experiment Phase, 63 patients will be enrolled and receive 30 mg Chidamide BIW and 400 mg Envafolimab Q4W, to evaluate the efficacy and safety of Chidamide when in combination with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC. This study is also to explore the gene expression and variation, PD-L1 and HDAC2 proteins expression levels in tumor tissue samples, the circulating tumor DNA (ctDNA) in plasma, and the potential correlation between peripheral blood cytokines and clinical preliminary efficacy and safety.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Southern Medical University Affiliated Nanfang Hospital, Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
Baoding No.2 Central Hospital, Baoding, Hebei, China
Henan Cancer Center, Zhengzhou, Henan, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Linyi Cancer Hospital, Linyi, Shandong, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Shanghai East Hospital, Shanghai, Shanghai, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Li Zhang
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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