NSCLC patients with EGFR-sensitive mutations (including L858R or Exon 19Del)
Conditions
Interventions
Intervention group:zorifertinib combined with radiotherapy
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The subject has fully understood this study and voluntarily signed the Informed Consent Form (ICF); 2.The subject is aged between 18 and 80 years old at the time of signing the ICF; 3.The subject has been diagnosed with NSCLC (confirmed by histology or cytology) accompanied by EGFR-sensitive mutations (including L858R or Exon 19Del) and is not eligible for curative surgery; 4.The subject has been diagnosed with brain parenchymal metastases (BM) via imaging, with =1.5 x 10^9/L; Platelet >=100 x 10^9/L; Hemoglobin >=90 g/L; Serum creatinine =50 mL/min; Total serum bilirubin = 3 months; 10.The subject has an ECOG performance status score of <=1.
Exclusion criteria
Exclusion criteria: 1.Subjects who have undergone major surgical procedures (e.g., intrathoracic, intra-abdominal, or pelvic surgery) within 4 weeks prior to the first dose of study treatment, or who have not yet recovered from the side effects of such surgery, are not eligible for enrollment; 2.Subjects with leptomeningeal metastases only; 3.Subjects with additional malignancies other than NSCLC, or a history of other malignancies within the past 5 years, except for the following: completely resected basal cell and squamous cell carcinomas of the skin, and any type of carcinoma in situ that has been curatively resected; 4.Subjects with clinically significant, uncontrolled heart disease and/or cardiac-related events within the past 6 months, such as: (1) Myocardial infarction within 6 months prior to the screening period; (2) Documented history of heart failure (NYHA Class III-IV); (3) Uncontrolled hypertension: systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg, with or without antihypertensive medication; adjustments to antihypertensive medication are permitted prior to the screening period; (4) Arrhythmias not controlled by medication; (5) QTcF > 470 ms during the screening period; (6) Left ventricular ejection fraction (LVEF) < 50%; 5.Subjects with gastrointestinal diseases or severely impaired gastrointestinal function that may significantly affect drug absorption (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome); 6.Subjects who cannot discontinue the following medications within 1 week prior to study drug administration and during the study period: (1) Strong inducers or strong inhibitors of CYP3A4; (2) Drugs that may prolong the QT interval or induce torsade de pointes; 7.Subjects with a prior or concurrent HIV infection are not eligible for enrollment. Subjects who are HCV antibody-positive may be enrolled if HCV-RNA is undetectable (the lower limit of normal for HCV-RNA detection shall be based on the reference values of each center) and there is no concurrent hepatitis B virus (HBV) infection. Subjects with HBV infection may be enrolled if the following conditions are met: • Subjects with active hepatitis B must meet the following criteria: antiviral treatment for at least 6 weeks prior to the start of study treatment, HBV DNA < 100 IU/mL, and ALT and AST levels < ULN. • Subjects with resolved or chronic hepatitis B must meet the following criteria: the subject has received prophylactic antiviral treatment for at least 2-4 weeks prior to the start of study treatment, HBV DNA < 100 IU/mL (e.g., inactive carriers), and ALT and AST levels < ULN; 8.Pregnant or breastfeeding women; women of childbearing potential and fertile men are required to use highly effective contraceptive methods during the administration of zorifertinib and for 3 months after the last dose; 9.Subjects with other severe, acute, or chronic medical conditions (e.g., uncontrolled diabetes or psychological disorders) or laboratory abnormalities that, in the investigator's judgment, would pose additional risks to the subject if participating in the study or would complicate the interpretation of study results; 10.Subjects with a prior history of interstitial lung disease, including clinically significant radiation pneumonitis (e.g., affecting daily life or requiring therapeutic intervention); 11.Subjects with a known history of allergy to the active ingredient or excipients of zorifertinib, or to drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Safety;Progression-Free Survival 2;Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactWang Ying
Chongqing University Cancer Hospital
Outcome results
None listed