High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

Required: EGFR exon 19 deletion

Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation. These mutations above may exist alone or together.

Required: EGFR L858R

Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation. These mutations above may exist alone or together.

Excluded: EGFR exon 20 insertion

Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis [excluded].

Cannot have received: EGFR tyrosine kinase inhibitor

Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)

Cannot have received: systemic anti-cancer therapy

Exception: except neoadjuvant or adjuvant therapy before 6 months prior to the first dose investigational treatment

Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose investigational treatment.