A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib

Inclusion Criteria

• •1. Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.
• •2. Gender was not limited patients aged ≥18 years at the time of signing the informed consent.
• •3. Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).
• •For patients in the dose-escalation cohort (Part A) of the escalation part:
• •Patients must have experienced disease progression following at least one line of prior standard systemic therapy, but no more than two lines of systemic therapy.
• •For patients in the dose confirmation cohort (Part B) of the escalation part :
• •1. Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);
• •2. Documented or central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
• •For patients in the expansion cohort of the expansion part :
• •1. Patients who have not received prior systemic therapy for locally advanced or unresectable/metastatic disease;
• •2. Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
• •4. Tumor tissue or blood test report confirmed KRASG12C mutation.
• •5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
• •7. Expected survival time of ≥3 months.
• •8. Patients must have adequate organ and bone marrow function.