A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression
A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression
Sponsor: Guangdong Association of Clinical Trials + Innovent Biologics, Inc., Akesobio
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression Free Survival(PFS) per Response Evaluation Criteria in Solid tumors (RECIST) v1.1
Time frame: From the start of treatment until disease progression or death (assessed up to 24 months)
Secondary Endpoints
Object Response Rate (ORR)
Disease Control Rate(DCR)
Duration of Response(DOR)
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent must be signed before implementing any trial-related procedures; 2. Age ≥18 years old; 3. Have histologically or cytologically confirmed locally advanced (IIIB/IIIC stage), metastatic or recurrent (IV stage) non-small cell lung cancer (NSCLC) that is not operable and not suitable for radical concurrent chemoradiotherapy, as classified by the 9th edition of the TNM staging system of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer; 4. Previously received first-line PD-1/PD-L1 inhibitor monotherapy or combination therapy, with a progression-free survival (PFS) of ≥ 6 months under the initial PD-1/PD-L1-containing treatment regimen; 5. Previously received only first-line systemic treatment; 6. Able to provide 15 pieces of biopsied tumor tissue or tumor tissue sections after PD-1/PD-L1 treatment resistance, pathologically confirmed as non-small cell lung cancer, and centrally laboratory-co…
Read full criteria on CT.gov →✦ Analyst Commentary
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