Non-small cell lung cancer
Conditions
Interventions
Observation group (Based on the patients wishes, accept erlotinib adjuvant targeted therapy for 2 years (125 mg TID) until tumor progression or the patient develops intolerable toxicity.):None
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Gender: Both males and females are eligible, with a preference for a balanced distribution; 3. Confirmed clinically to have stage II-IIIA lung adenocarcinoma (8th edition of AJCC) with operable conditions; 4. Confirmed by postoperative pathological examination to have R0 resection and EGFR gene 21 exon L858R and 19 exon deletion mutations; 5. Accepting follow-up and receiving erlotinib adjuvant therapy after surgery; 6. ECOG performance status score of 00-11, with an expected survival time of more than 1 year; 7. The organ function levels must meet the following requirements: (1) Bone marrow: Absolute neutrophil count (ANC) >= 1.5×10^9/L, platelets >= 100×10^9/L, hemoglobin >= 9g/dl; (2) Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) = 60 ml/min; 8. Women of childbearing age must undergo a pregnancy test within 7 days before the start of treatment and have a negative result. They must take contraceptive measures during the treatment period and within 3 months after the end of treatment. Men of childbearing age must undergo surgical sterilization or take contraceptive measures during the treatment period and within 3 months after the end of treatment; 9. Understand and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received any systemic anti-tumor treatment, including chemotherapy, radiotherapy, or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) before entering this study; 2. Diagnosed with cancer within the past 2 years; 3. Clinical and objective evidence (pathological or imaging) of tumor recurrence before the start of adjuvant therapy; 4. Known allergy to any component of erlotinib hydrochloride; 5. History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; idiopathic pulmonary fibrosis detected by baseline CT scan; 6. Evidence of severe or uncontrollable systemic diseases, such as unstable or uncompensated respiratory, cardiac, liver, or kidney diseases, as determined by the investigator; 7. Any unstable systemic disease (including active infection, grade III hypertension, unstable angina pectoris, congestive heart failure, liver, kidney, or metabolic disease); 8. A history of clear neurological or psychiatric disorders, including epilepsy or dementia; 9. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection, etc.; 10. Pregnant or lactating women; 11. Other situations in which the investigator considers the patient ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS);Overall survival (OS);Median time to relapse of patients with MRD detected by imaging in advance;Clinical benefit difference of patients with different duration of icotinib treatment;Difference in the efficacy of 2-year adjuvant icotinib treatment for different MRD statuses;Change in MRD status before and after 2-year adjuvant icotinib treatment; | — |
Countries
China
Contacts
Public ContactLanjun Zhang
Department of Thoracic Surgery, Sun Yat-Sen University Cancer Center
Outcome results
None listed