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

Prior treatment

• Toxicities from prior antitumor therapy have not returned to baseline or stabilized.
• Any condition requiring systemic treatment with corticosteroids.

Other illness

• Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.
• The patient currently has active interstitial lung disease.
• Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.
• Uncontrolled or significant cardiovascular disease.
• Has a known human immunodeficiency virus (HIV) infection that is not well controlled.
• Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study

Other

• Patients with active brain metastases.

• Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.
• Gender was not limited patients aged ≥18 years at the time of signing the informed consent.
• 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 :
  • Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);
  • 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 :
  • Patients who have not received prior systemic therapy for locally advanced or unresectable/metastatic disease;
  • Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
• Tumor tissue or blood test report confirmed KRASG12C mutation.
• Patients must have at least one measurable lesion as defined by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
• Expected survival time of ≥3 months.
• Patients must have adequate organ and bone marrow function.