A multicenter, single-arm Phase II study to evaluate the efficacy and safety of fulzerasib (IBI351) in combination with ivonescimab (AK-112) in first-line treatment of advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
Sign the Informed Consent Form (ICF) and be able to comply with the visit and related procedures as stipulated in the protocol.
Be male or female, aged ≥18 and ≤75 years old.
Have an expected survival time of ≥6 months.
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 8th edition of the TNM staging system of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer.
Experienced definite cardiovascular abnormal events within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or undergone angioplasty, vascular stent implantation, coronary artery bypass surgery, etc.
Have clinically significant QT/QTcF interval prolongation (QTcF > 470ms for females or > 450ms for males).
Experienced definite cerebrovascular abnormal events within 3 months, such as cerebral hemorrhage or cerebral infarction.
Active infections requiring systemic treatment;
Shanghai Chest Hospital
Lead sponsor
Innovent Biologics, Inc.
Collaborator
Akesobio
Collaborator