Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II

This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

Inclusion criteria

• To provide a signed and dated, written informed consent.
• 80≥Age ≥ 18 years old
• Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
• EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
• Predicted life expectancy ≥ 12 weeks
• EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
• No previous systemic chemotherapy for advanced or metastatic disease.
• Adequate organ system function:
• Patient must have measurable disease according to RECIST 1.1.
• Patients with stable or pre-treated brain metastasis (BM) can be enrolled

Exclusion criteria

• Spinal cord compression or meningeal metastasis
• A history of malignant tumors within 2 years.
• With known resistant mutations that have approved target therapy
• Recover from AEs caused by previous treatment
• A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
• Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)