This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of Chidamide in combination with Ivonescimab in the treatment of advanced non-small cell lung cancer with secondary immune resistance and high YAP protein expression.
Written informed consent must be signed before implementing any trial-related procedures;
Age ≥18 years old;
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;
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;
Have a history of severe bleeding tendency or coagulation disorders; have significant clinical bleeding symptoms within 4 weeks before enrollment, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing or expectorating ≥ 1 teaspoon of fresh blood or small blood clots or only coughing blood without sputum, subjects with blood in sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retracted nasal blood); continuous antiplatelet or anticoagulant therapy within 14 days before the first dose;
History of gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), esophagogastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose; extensive intestinal resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea);
Hypersensitivity to any study drug or its components;
Exclusion of central squamous cell lung cancer invading large blood vessels;
Single group
Chidamide in combination with Ivonescimab
DrugChidamide 20mg/dose orally BIW; Ivonescimab 20mg/kg intravenously (IV) Q3W
Progression Free Survival(PFS) per Response Evaluation Criteria in Solid tumors (RECIST) v1.1
PFS is measured from the start of treatment until progression or death, whichever is first met
Object Response Rate (ORR)
ORR is defined as percentage of participants with Complete Response(CR) and Partial Response(PR), assessed by the investigators according to the RECIST 1.1.
Disease Control Rate(DCR)
DCR based on RECIST 1.1 assessed by the investigators, the proportion(%) of patients with at least one visit response of CR or PR, or SD.
Duration of Response(DOR)
DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 assessed by investigators.
Overall Survival
Overall Survival(OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.
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Guangdong Association of Clinical Trials
Lead sponsor
Innovent Biologics, Inc.
Collaborator
Akesobio
Collaborator