Non-small lung cancer
Conditions
Interventions
Control (MRD negative):Observe
Test (MRD positive):Osimertinib or observe
Sponsors
The Fourth People's Hospital of Kunming (Anning First People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men or women aged over 18 years; 2. Histologically confirmed non-small cell lung cancer; 3. Patients with stage Ia-IIa non-small cell lung cancer who received complete surgical radical resection with negative margins (R0) and complete lymph node dissection with EGFR mutations (except those reported in the literature that are associated with osimertinib resistance); EGFR mutations, such as L718Q, C797S, etc.); 4. Physical condition ECOG score of 0-1, and no deterioration within 2 weeks before enrollment. Expected survival of not less than 12 weeks; 5. Fully recovered from surgery before adjuvant therapy, and imaging examination showed no signs of tumor recurrence; 6. The clinical laboratory test indicators meet the following standards: (1) Platelets >= 100x10^9/L; (2) Absolute neutrophil count (ANC) >= 1.5x10^9/L, or absolute white blood cell count (WBC) >= 3.5x10^9/L; (3) Hemoglobin (Hgb) >= 100 g/L (no blood transfusion or erythropoietin use within 4 weeks); (4) Total bilirubin = 50 mL/min (calculated according to Cockcroft-Gault formula); (7) Serum amylase <= 2 times ULN or pancreatic amylase <= 1.5 times ULN; (8) Serum lipase <= 1.5 times ULN; (9) The subjects did not take anticoagulants, or the subjects who used anticoagulants in the past met the drug withdrawal for 28 days before enrollment, and the international normalized ratio (INR) <= 1.5 and activated partial thromboplastin time ( APTT) <= 1.5 times ULN; 7. Able to swallow oral medication; 8. By following the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with tumor components containing small cell lung cancer, neuroendocrine carcinoma, sarcoma, etc., or mixed pathological components were excluded; 2. Any type of systemic anticancer therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy; 3. Confirmation of objective clinical evidence of disease recurrence (pathology or imaging) prior to adjuvant therapy; 4. Past history of ILD, drug-induced ILD, or evidence of any clinically active ILD; baseline CT scan showed the presence of idiopathic pulmonary fibrosis; 5. Clinically uncontrollable pleural effusion/peritoneal effusion; 6. Glucocorticoid therapy (>10 mg prednisone equivalent dose per day) 28 days before the first dose; 7. Have active autoimmune disease requiring systemic treatment (ie, use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy and is permitted; 8. Allergy to osimertinib or any of its ingredients; 9. Those who are judged by the investigator to be unsuitable to participate in this study; 10. Allogeneic tissue/solid organ transplantation has been performed; 11. Except for alopecia and stable sub-grade 2 peripheral neurotoxicity, any clinical toxicity related to previous treatment prior to enrollment did not return to pre-treatment levels or grade 1; 12. Pregnancy status (blood HCG positive) and lactation period; 13. There is no complete clinicopathological information and follow-up; 14. Liver viral infection, without antiviral treatment, including active viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, hereditary liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 6, 12, and 24 month Disease free survival (DFS) rates and patients' quality of life; | — |
Countries
China
Contacts
Public ContactKun Wang
The Fourth People's Hospital of Kunming (Anning First People's Hospital)
Outcome results
None listed