non-small cell lung cancer, NSCLC
Conditions
Interventions
Firmonertinib treatment group:NA
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Obtain written informed consent from the patient. 2. Male or female, aged 18 years or older. 3. Histologically confirmed primary non-squamous non-small cell lung cancer (nsNSCLC). 4. Completion of radical lobectomy and systematic lymph node dissection, with all gross lesions completely removed at the end of surgery, and all surgical resection margins of the tumors must be negative (systematic lymph node dissection must include 6 groups, with 3 groups from intrapulmonary (lobar, interlobar, or segmental) and hilar lymph nodes, and 3 groups from mediastinal lymph nodes including subcarinal lymph nodes). 5. Postoperative pathological staging of IA2-IB (AJCC 9th edition), with at least one high-risk factor for recurrence (high-risk factors for recurrence include: vascular invasion; visceral pleural invasion; aerogenous metastasis; histological patterns with micropapillary, solid, or cribriform components accounting for 10% or more). 6. Tumor tissue NGS testing showing positive for EGFR-sensitive mutations (Ex19del,L858R,G719X,S768I,L861Q mutations, with or without T790M mutation).
Exclusion criteria
Exclusion criteria: 1. Anti-tumor therapy for the purpose of neoadjuvant or adjuvant treatment, including radiotherapy, chemotherapy, targeted therapy, and immunotherapy; 2. Previous treatment with other EGFR-TKIs; 3. Patients deemed unsuitable for inclusion by the investigator, such as those with neurological or metabolic disorders, suspected diseases based on physical or laboratory examinations, contraindications to the study drug, or high risk of treatment-related complications; 4. Lactating women; 5. History of other malignancies, or currently concurrent malignancies in other organs or sites (except for malignancies that have undergone radical surgery and have not recurred within 5 years postoperatively, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS rate for 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;DFS rate for 3/5 years;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactQingyi Liu
The Fourth Hospital of Hebei Medical University
Outcome results
None listed