Non-small cell lung cancer
Conditions
Interventions
Experimental group:Furmonertinib 160mg Oral QD
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signed informed consent obtained from the patient or their legal representative; 2.Age >=18 years; 3.Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) NSCLC, as per the 9th edition of the IASLC/AJCC TNM staging system, and ineligible for definitive concurrent chemoradiotherapy; 4.Availability of pretreatment tumor tissue or cytology specimens for molecular testing, confirming the presence of an EGFR mutation (exon 19 deletion or L858R) with concurrent TP53 co-mutation; 5.ECOG performance status of 0–1 and life expectancy >=12 weeks; 6.At least one measurable lesion per RECIST v1.1 criteria; 7.No prior systemic anti-tumor therapy for the current disease; 8.For subjects with brain metastases: Clinically stable for >=4 weeks prior to the first dose of study treatment,No requirement for corticosteroids or anticonvulsants for >=14 days prior to the first dose, No need for immediate local therapy for brain metastases per investigator assessment; 9.Adequate organ function (bone marrow, hepatic, renal, and coagulation); 10.Willing and able to comply with study procedures, including oral drug administration.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity history to active/inactive excipients of furmonertinib or drugs with similar structures/pharmacological classes to the investigational product; 2.Confirmed EGFR exon 20 insertion mutations or other uncommon EGFR mutations (e.g., G719X, L816Q, S761I); 3.Prior systemic anti-tumor therapy for advanced/metastatic NSCLC (including standard chemotherapy, biologics, targeted therapy, immunotherapy, or investigational drugs); 4.Other malignancies within 5 years (except adequately controlled basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast); 5.Uncontrolled systemic diseases (e.g., hypertension, diabetes, active bleeding) that may compromise protocol compliance per investigator assessment; 6.Severe comorbidities, including:Active/uncontrolled infections (e.g., tuberculosis, HIV), decompensated liver disease or active hepatitis, active bleeding; cerebrovascular events or pulmonary embolism; active/known/suspected autoimmune diseases; 7.Clinically significant abnormalities affecting safety evaluation: (1).Ventricular/supraventricular arrhythmias or atrial fibrillation requiring medication (QTcB >480 ms); (2).Grade =3 congestive heart failure (NCI-CTCAE v5.0), unstable angina, or myocardial infarction within 6 months; (3).Extensive drug-treated interstitial lung disease; 8.Prior treatments within specified timeframes: (1).Any prior EGFR-TKI therapy; (2).Intrapleural therapy (eligible only if pleural effusion stabilized >=28 days); (3).Major surgery (Grade 3/4 per Chinese Clinical Application of Medical Technology Management, 2009) within 28 days before dosing; (4).Radiation involving >=30% bone marrow or wide-field radiotherapy within 28 days, or palliative/local radiotherapy within 14 days; (5).Strong CYP3A4 inhibitors/inducers within 7 days; (6).Antitumor traditional Chinese medicines within 7 days; (7).QT-prolonging drugs with torsades de pointes risk; (8).Other investigational drugs within 5 half-lives or 2 months (whichever is longer); 9.Symptomatic CNS involvement: spinal cord compression or symptomatic brain metastases (except asymptomatic/stable lesions without steroids =28 days); post-radiation patients eligible only if neurologically stable >=28 days after radiotherapy; 10.Pregnancy or lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactHongbing Liu
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed