Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations

Inclusion Criteria:

• ≥ 18 years old, Male or Female

• Histologically or cytologically confirmed locally advanced or metastatic lungadenocarcinoma not amenable to curative surgery or radiotherapy;

• Patients have been confirmed by local laboratory to have one of the following EGFRmutations: 19Del or L858R (single or compound)

• Patients had locally advanced NSCLC or metastatic NSCLC without any systemicantitumor 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 usedfor biopsy in screening period; if there is only one measurable lesion, this lesionwill be permitted to be biopsied. However, the baseline radiological examination canbe 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 timesULN); (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 toscreening

• Life expectancy > 12 weeks after the first dose of investigational product

• Female of childbearing age are not pregnant and have no pregnancy plan. Femalesubjects at childbearing age and male subjects agree to take effective contraceptivemeasures during the study and within 6 months after drug discontinuation

• Being able to understand and voluntarily participate in the study, and sign theinformed consent form.

Exclusion Criteria:

• NSCLC with predominant squamous cell histology, small cell lung cancer orneuroendocrine carcinoma indicated by histology or cytology test

• Patients with other driver oncogenes (ALK fusion, ROS1 fusion, RET rearrangement,BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, but not TP53, RB1, BRACmutation, etc.);

• Expected to receive other anti-tumor therapy other than the investigational productduring the study

• Having received the following therapies: (1) Having been irradiated for > 30% bonemarrow or a large area within 4 weeks prior to the first dose of investigationalproduct; (2) Having received major surgery within 4 weeks prior to the first dose ofinvestigational product or plan to receive major surgery during the study withexception of the surgical procedures to establish vascular access, biopsy throughmediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 daysprior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditionalChinese medicine or traditional Chinese medicine preparation with tumor indication,or traditional Chinese medicine or traditional Chinese medicine preparation withadjuvant anti-tumor effect within two weeks prior to the first dose ofinvestigational product or expected to be required during the study; (4) Havingparticipated in the clinical trial and received the investigational product ordevice within 4 weeks or at least 5 half-lives prior to the first dose ofinvestigational product; (5) Having received other anti-tumor drugs within 14 daysprior to the first dose of investigational product;

• Concurrent spinal cord compression or symptomatic brain metastasis

• The toxicity caused by previous anti-tumor therapy has not recovered to <= CTCAEgrade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-relatedneurotoxicity) or the level specified in the inclusion/exclusion criteria;

• Unstable pleural effusion or peritoneal effusion with obvious symptoms; those withstable clinical symptoms for at least 14 days after drainage of pleural effusion orascites will be eligible

• Having a history of other malignant tumor, or other concurrent malignant tumors (except those that have undergone radical operation and have no recurrence within 5years post operation, e.g. cervical carcinoma in situ, basal cell carcinoma of skinand papillary thyroid carcinoma)

• Previous interstitial lung disease (ILD), drug-induced interstitial lung disease,radiation pneumonitis requiring steroid therapy; or having the clinicalmanifestations of suspected interstitial lung disease

• Having severe or uncontrolled systemic disease requiring treatment that isconsidered by investigators as ineligible for the study, including hypertension,diabetes, chronic heart failure (NYHA Functional Classification III-IV), unstableangina pectoris, myocardial infarction within one year, active hemorrhagic disease,etc.

• QTc > 470 ms on ECG at resting state

• Clinically significant prolonged QT interval or other arrhythmia or clinical statusconsidered by investigators that may increase the risk of prolonged QT interval; forexample, complete left bundle branch block, degree III atrioventricular block,congenital long QT syndrome, serious hypokalemia, or current use of drugs that maylead to prolonged QT interval

• Serious gastrointestinal dysfunction, or disease that may affect the intake,transportation or absorption of investigational product

• Infectious disease requiring intravenous medication

• Known history of mental disease or drug abuse, and currently having an attack orstill taking drugs

• Known or suspected allergy to Furmonertinib or other components of its preparation

• Female subjects or female partners of male subjects who are pregnant or lactating,or plan to be pregnant during the study

• Poor compliance, inability to comply with the study procedures, restriction orrequirements

• Other conditions that are considered by investigators as unsuitable to participatein this study.