The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study
To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
• ≥ 18 years old, Male or Female
• Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;
• Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)
• Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy
• Having at least one measurable lesion (in accordance with RECIST1.1). Note: measurable lesion can neither be subject to local therapy as radiotherapy nor used for biopsy in screening period; if there is only one measurable lesion, this lesion will be permitted to be biopsied. However, the baseline radiological examination can be performed for this lesion at least 14 days after biopsy
• Adequate organ function as shown in the laboratory test, including: (1) ANC \>= 1.5 x 10\^9/L; PLT \>= 100 x 10\^9/L; HGB \>= 90 g/L; (2) TBIL \<= 1.5 times ULN, AST and ALT \<= 2.5 times ULN (with liver metastasis, TBIL \<= 3 times ULN, AST and ALT \<= 5 times ULN); (3) CrCL \>= 50 mL/min (according to Cockcroft-Gault formula);
• ECOG PS 0-1, and there was no obvious disease deterioration within 2 weeks prior to screening
• Life expectancy \> 12 weeks after the first dose of investigational product
• Female of childbearing age are not pregnant and have no pregnancy plan. Female subjects at childbearing age and male subjects agree to take effective contraceptive measures during the study and within 6 months after drug discontinuation
• Being able to understand and voluntarily participate in the study, and sign the informed consent form.