Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)
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.
• 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