lung cancer
Conditions
Interventions
treatment group:Administer icotinib according to MRD status
control group:Administer icotinib for 3 years
Sponsors
Peking University People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Ability to understand and the willingness to sign informed consent before participating in the study. 2.Age >= 18 years old. 3.Preoperative detection of EGFR sensitizing mutations (exon 19 deletion or L858R mutation in exon 21) in ctDNA. 4.The postoperative histological diagnosis was resected IIIA/IIIB non-squamous non-small cell lung cancer (AJCC 8). 5.Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization. No more than 10 weeks may have elapsed between surgery and randomization for patients who have not received adjuvant chemotherapy; no more than 26 weeks may have elapsed between surgery and randomization for patients who received adjuvant chemotherapy. - Complete post-operative wound healing must have occurred following any surgery - For patients who received post-operative adjuvant platinum-based chemotherapy, a minimum of 2 weeks must have elapsed (but no more than 10 weeks) from the last administered dose of chemotherapy to the date of randomization. - Patients must have recovered from all toxicities of prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy. 6.ECOG score: 0-1 7.Adequate organ function: Absolute neutrophil count (ANC) >= 1.5x109/L Platelets >= 100×109/L Hemoglobin > 9.0 g/dL AST, ALT = 60ml/min Normal blood clottingnormal INR range or prothrombin time (PT) <= 1.5 x ULN. 8. For female subjects of childbearing potential, a urine or serum pregnancy test with a negative result should be performed within 7 days prior to the first dose of study drug. If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be required. Women of non-reproductive age are defined as being at least 1 year post-menopausal or having undergone surgical sterilization or hysterectomy. 9. If there is a risk of conception, all subjects (male or female) are required to use highly effective contraception throughout the treatment period up to 120 days after the end of treatment administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Treatment with any of the following: (1) Pre-operative or post-operative or planned radiation therapy for the current lung cancer (2) Pre-operative (neo-adjuvant) platinum-based or other chemotherapy (3) Any prior anticancer therapy , including investigational therapy, for treatment of NSCLC other than standard platinum based doublet post-operative adjuvant chemotherapy (4) Prior treatment with neoadjuvant or adjuvant EGFR-TKI (5) Major surgery was performed within 4 weeks before the first administration of the study drug (6)Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior) 2. Patients who have had segmentectomies or wedge resection, and those who have not undergone lymph node dissection 3. Past medical history of ILD, drug-induced ILD, or any evidence of clinically active ILD; Patients with idiopathic pulmonary fibrosis at baseline 4. Diagnosed with other malignant diseases within 2 years before the first administration 5. Any uncontrolled systemic diseases (1) Active infection (2) Autoimmune diseases that require medication or plasma exchange (3) uncontrolled hypertension(Systolic blood pressure =150mmHg and/or diastolic blood pressure =100) (4) unstable angina or angina within the last 3 months (5) myocardial infarction (6 months before enrollment) or Warfarin anticoagulation after cardiac stent operation (6) Uncontrolled asthma; chronic obstructive pulmonary disease (COPD); pulmonary hypertension (7) Renal insufficiency patients who need dialysis treatment 6. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value. (2) Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block (3) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. 7. Histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma 8. Allergy to icotinib or drugs with a similar chemical structure or any ingredients 9. Patients whose pathology was mixed small cell lung cancer 10. Pregnant or breastfeeding women 11. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of icotinib 12. Judgment by the Investigator that the patient should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to discontinuation; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;1/3/5 DFS rate ang OS rate;safety; | — |
Countries
China
Contacts
Public ContactFan Yang
Peking University People’s Hospital
Outcome results
None listed