Non-small cell lung cancer
Conditions
Interventions
Experimental group:The experimental group received icotinib treatment for 18 months.
Sponsors
Jining Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Pathologically confirmed non-small cell lung cancer (NSCLC) with standard radical lung cancer surgery (lobectomy or segmentectomy + hilar and mediastinal lymph node dissection/sampling); b. Postoperative pathological staging with high-risk pathological factors such as papillary/micropapillary/solid/mucinous components, with or without complex glandular structures in stage IA NSCLC; c. ct-DNA was positive or negative after surgery and before adjuvant therapy (4 weeks after surgery); d. Age >=18 years and <=75 years; e. ECOG or PS score of 0 or 1; f. The patient's primary NSCLC has classical EGFR mutations (EGFR 19 Del or 21 L858R); g. The diagnosed patient has not previously received lung cancer-related chemotherapy, radiotherapy, or targeted therapy; h. Normal function of major organs; i. Women of childbearing age or male subjects with partners of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period; complete postoperative recovery with no signs of tumor recurrence on imaging tests.
Exclusion criteria
Exclusion criteria: a. Insufficient bone marrow reserve; b. Presence of significant factors affecting the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.; c. Presence of a prior treatment-induced toxicity event that has not recovered to CTCAE version 5.0 grade 0 or 1 before the first dose of study treatment; d. Suffering from severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding, etc.; e. Known HIV-infected individuals and carriers (HIV antibody positive); f. Active infections requiring antimicrobial treatment (e.g., antibiotics, antiviral drugs, antifungal drugs); g. Patients with a history of interstitial lung disease or those concurrently suffering from interstitial lung disease; h. History of or concurrent untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; i. Those who have received strong CYP3A4 or CYP2C19 inducer treatment within 12 days before participating in the study; j. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470ms, screened using 3 ECG QTc values obtained from a clinical ECG machine; (2) Any clinically significant abnormalities in rhythm, conduction, or morphology on resting ECG; (3) Any factors that increase the risk of QTc prolongation or arrhythmic events, or a first-degree relative with unexplained sudden death under the age of 40 or taking any drugs known to prolong the QT interval; k. Patients who have not recovered from major complications after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZiteng Zhang
Jining Medical University Affiliated Hospital
Outcome results
None listed