non-small cell lung cancer
Conditions
Interventions
Test group:Limertinib
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent prior to participation in any study-related procedures. 2. Age >= 18 years. 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). 4. Postoperative pathological stage II-IIIA (AJCC 8th edition). 5. Histological testing confirming the presence of an uncommon EGFR sensitizing mutation (EGFR G719X, L861Q, S768I, or EGFR exon 20 insertion). 6. Complete resection of the primary NSCLC lesion (R0 resection). 7. Full recovery from surgery and completion of standard postoperative therapy (if applicable). 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 9. Life expectancy > 3 months. 10. Adequate organ function, defined as the following laboratory values within 14 days prior to the first dose of study drug: 1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (without granulocyte colony-stimulating factor support within 14 days). 2) Platelet count >= 100 x 10^9/L (without transfusion within 14 days). 3) Hemoglobin > 9.0 g/dL (without transfusion or erythropoietin use within 14 days). 4) Total bilirubin = 60 mL/min. 7) Adequate coagulation, defined as International Normalized Ratio (INR) or prothrombin time (PT) <= 1.5 x ULN. 8) Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may be enrolled if both Total T3 (or Free T3) and Free T4 are within normal limits. i) Normal myocardial enzyme profile (isolated laboratory abnormalities judged by the Investigator as clinically insignificant are acceptable). 11. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to receiving the first dose of study drug (Cycle 1, Day 1). A serum pregnancy test is required if the urine test result is inconclusive. Non-childbearing potential is defined as being post-menopausal for at least 1 year, or having undergone surgical sterilization (bilateral oophorectomy, salpingectomy, or hysterectomy). 12. For subjects with childbearing potential, effective contraception with a method associated with a failure rate of <1% per year must be used by both male and female subjects during the treatment period and for at least 120 days (or 180 days, consult protocol) after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of small cell lung cancer (SCLC), including combined SCLC and NSCLC. 2. Prior treatment as follows: Preoperative, postoperative, or planned radiotherapy for the current lung cancer. Preoperative (neoadjuvant) platinum-based or other chemotherapy regimens. Any prior antineoplastic therapy for NSCLC (including investigational therapy), except for standard adjuvant platinum-doublet chemotherapy. Prior neoadjuvant or adjuvant EGFR-TKI therapy. Major surgery (including primary tumor surgery, excluding vascular access placement) within 4 weeks prior to the first dose of study drug. Current use of or inability to discontinue strong CYP3A4 inducers (requires a washout period of at least 3 weeks) prior to the first dose. Use of an investigational drug or related material within 5 half-lives of the known compound. 3. Patients who underwent only segmentectomy or wedge resection are excluded, as the limited surgical extent may impact efficacy evaluation. 4. History of other malignancies, except for: cured non-melanoma skin cancer, carcinoma in situ, or other solid tumors treated and with no evidence of recurrence for >5 years (investigator must assess as low risk of recurrence). 5. At the start of study treatment, toxicities from prior therapy must have recovered to = Grade 1 per CTCAE (except alopecia and Grade 2 neuropathy related to prior platinum therapy, which are allowed). 6. Uncontrolled hypertension, active bleeding disorders, or active infections requiring intravenous therapy (e.g., hepatitis B, hepatitis C, HIV), or other conditions that, in the investigator's judgment, may compromise safety or protocol compliance. 7. Refractory nausea/vomiting, chronic gastrointestinal diseases, dysphagia, or prior significant bowel resection that may interfere with the normal absorption of limertinib. 8. Cardiac function criteria: Prolonged QTc interval: average resting corrected QTc >470 msec (based on 3 ECGs). Significant ECG abnormalities: e.g., complete left bundle branch block, third-degree atrioventricular block. Risk factors for arrhythmia: hypokalemia, congenital long QT syndrome, family history of long QT syndrome, etc. 9. History of interstitial lung disease (ILD), radiation pneumonitis requiring steroid treatment, or active ILD. 10. Clinically significant laboratory abnormalities: Myelosuppression: Neutrophil count 2.5 x ULN, total bilirubin >1.5 x ULN (>3 x ULN for Gilbert's syndrome). Renal impairment: Serum creatinine >1.5 x ULN and? calculated creatinine clearance 5 years (investigator must assess as low risk of recurrence). 5. At the start of study treatme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year DFS rate;Disease-free survival (DFS);Overall survival (OS);Safety; | — |
Countries
Chin
Contacts
Public ContactShiwang Wen
The Fourth Hospital of Hebei Medical University
Outcome results
None listed