At least one measurable lesion in accordance with RECIST 1.1
Must have an ECOG performance status of 0 or 1.
Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
Documentation of the presence of a KRAS G12C mutation
Must provide tumor tissue sample
No history of systemic anticancer therapy in metastatic/non-curable settings
Estimated life expectancy ≥12 weeks.
Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.
Females must have the evidence of non-childbearing potential; Likewise, men also consent to use adequate contraceptive method within the same time limit.
Signed and dated Informed Consent Form.
The subjects are able to comply with the process of the protocol.
You may not be if
Treatment with any of the following:
1. Previous or current treatment with other KRAS G12C inhibitors
2. Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of study treatment; Any investigational agents and large molecule antibodies within 28 days of the first dose of study treatment.
3. Local radiotherapy within 2 weeks prior to the first dose of study drug, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of study drug.
4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose
Active brain metastases.
Patients with uncontrolled pleural, ascites or pericardial effusion
Spinal cord compression
Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
History of other primary malignancies.
Inadequate bone marrow reserve or organ functions.
Abnormal cardiac examination results.
Severe, uncontrolled or active cardiovascular disorders.
Diabetes ketoacidosis or hyperglycemia hyperosmolality
Uncontrolled hypertension.
Severe bleeding symptoms or bleeding tendencies.
Severe arteriovenous thrombosis occurred
Serious infection.
Continuous use of glucocorticoids
Active infectious diseases.
Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
