Therapy for Advanced NSCLC With EGFR 19delins Mutation

Prior treatment

• Underwent major surgery or immunotherapy within 4 weeks prior to the first dose; received radiation therapy within 2 weeks prior to the first dose;

Other illness

• Active hepatitis B, positive for hepatitis C virus antibody, positive for human immunodeficiency virus (HIV) antibody, or positive for Treponema pallidum antibody;
• Patients with imaging evidence of tumor invasion of major blood vessels, or those judged to have a very high likelihood of tumor invasion of critical blood vessels leading to fatal massive hemorrhage during the subsequent study period;
• History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; presence of idiopathic pulmonary fibrosis on baseline CT scan;
• Any other conditions deemed by the investigator to make the subject unsuitable for participation in this trial.

Lab values

• Women of childbearing potential with a positive serum pregnancy test within 7 days prior to initiation of treatment, pregnant or lactating women, or male and female subjects who are not using effective contraception or plan to conceive during the entire treatment period and for 3 months after the end of treatment;
• Patients who have used any of the following medications within 14 days prior to the first dose or require concomitant use of such medications during treatment: drugs with a risk of causing QTc prolongation and/or torsade de pointes; strong inhibitors or strong inducers of CYP3A;
• Other severe, acute, or chronic medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results, including uncontrolled diabetes mellitus, medical or psychiatric illnesses, or laboratory abnormalities;

Other

• Advanced and/or symptomatic brain metastases (measurable or non-measurable) and/or leptomeningeal metastases;

• Age ≥ 18 years;
• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC Cancer Staging Manual, 9th edition, Stage IIIB, IIIC or IV) that is not amenable or suitable for surgical resection or other radical therapies, as assessed by the investigator;
• Epidermal growth factor receptor (EGFR) exon 19 deletion-insertion mutation (19delins) documented by testing of tumor tissue or plasma samples using methods including IHC, NGS, ARMS, etc.;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
• No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
• Life expectancy ≥ 12 months;
• At least one measurable lesion by imaging in the screening period according to RECIST v1.1;
• Ability to swallow and retain oral medication;
• Adequate organ system function;
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and agree to use a medically accepted highly effective method of contraception during the study and for 3 months after the last dose of study drug;
• Voluntary and able to comply with study and follow-up procedures; Ability to understand the nature of the trial and provide written informed consent.