First-line Furmonertinib in Advanced NSCLC Patients With EGFR Uncommon Mutation

Inclusion Criteria:

• Provide informed consent prior to any study specific procedures;
• 18 -70 years of age;
• ECOG PS of 0 to 1 at screening with no clinically significant deterioration in theprevious 2 weeks, life expectancy ≥12 weeks;
• Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);
• Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system);
• Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically orcytologically, the reports must be issued or recognized by Tier 3A hospitals. Themutations above may exist alone or together;
• No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
• According to RECIST 1.1, patients have at least one tumor lesion at baseline thatmeets the following requirements: accurately and repeatably measurable at baselinehave no radiotherapy or biopsy;
• For premenopausal women with childbearing potential, a pregnancy test must beperformed within 14 days before the first dose, and the pregnancy test (blood or urinetest) must be negative; female subjects must not be lactating;
• Willing to use contraception (male patients); Voluntary and agree to follow the studytreatment protocol as well as follow-up plan, and can accept the oral medicinetreatment.

Exclusion Criteria:

• small cell lung carcinoma;
• History of hypersensitivity to active or inactive excipients of investigationalproduct (IP) or drugs with a similar chemical structure or class to investigationalproduct (IP);
• Confirmed EGFR Ex20ins or Ex19del or L858R or T790M mutant;
• Patient who receive prior treatment including: any Epidermal growth factor receptortyrosine kinase inhibitors (EGFR-TKI); the patients who have received intrapleuralperfusion therapy can only be enrolled 28 days or more after the pleural effusion isstable; major surgery within 4 weeks of the first dose of investigational product (IP); radiotherapy treatment to more than 30% of the bone marrow or with a wide fieldof radiation within 4 weeks of the first dose of IP; CYP3A4 strong inhibitor or stronginducer is used within 7 days prior to the first dose, or need to receive these drugsduring the study period; traditional Chinese medicine and traditional Chinese medicinepreparations with anti-tumor as indications and with adjuvant treatment of tumor isused within 7 days prior to the first dose, or need to receive these drugs during thestudy period; patients who are receiving drugs known to prolong QTc interval or maycause torsade de pointe and need to continue to receive these drugs during the studyperiod; the time from the treatment with any other investigational product or itsanalogue to the first dose does not exceed 5 half-lives of the drug or 14 days,whichever is longer.
• Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell LungCancer (NSCLC) including chemotherapy, biologic therapy, target therapy,immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapybefore 6 months prior to the first dose IP;
• At the beginning of study treatment, any unresolved toxic reaction to prior treatmentis present, which exceeds Grade 1 in accordance with Common Terminology Criteria forAdverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinumtreatment-related neuropathy;
• Spinal cord compression; symptomatic and unstable brain metastases, except for thosepatients who have completed definitive therapy, are not on steroids, and have a stableneurological status for at least 2 weeks after completion of the definitive therapyand steroids.
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability toswallow the formulated product, or previous significant bowel resection that wouldpreclude adequate absorption of IP;
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolledhypertension, active bleeding diatheses, and active infection, which in theInvestigator's opinion makes it undesirable for the patient to participate in thetrial;
• Past medical history of Interstitial Lung Disease (ILD), drug-induced InterstitialLung Disease, radiation pneumonitis that required steroid treatment, or any evidenceof clinically active Interstitial Lung Disease;
• Any evidence of corneal injury;
• Inadequate bone marrow reserve or organ function;
• QT prolongation or any clinically important abnormalities in rhythm and heartfunction;
• Pregnancy or lactation;
• Patients who may have poor compliance with the research procedures and requirements,etc., as judged by investigators.