lung cancer
Conditions
Interventions
Case series:Neoadjuvant targeted therapy
Sponsors
Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as IIIB or IV non-small cell lung cancer (according to the eighth edition of UICC lung cancer TNM staging diagnostic criteria); 2. received no anti-tumor therapy; 3. The presence of sensitive EGFR mutations (19-DEL / L858R); 4. After targeted therapy by PET-CT examination to = stage of IIIA ; 5. Physical status ECOG score of 0-1; 6. Patients with organ functional levels must meet the following requirements: 1) Blood: neutrophil absolute count (ANC) = 2.0 * 10^9/L, platelet =100 * 10^9/L, hemoglobin = 9g / dl; 2) liver: bilirubin = 1.5 times the normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the normal upper limit; 3) kidney: serum creatinine = 1.25 times the upper limit of normal or creatinine clearance = 60ml / min; 7. Women of childbearing age must be pregnant within one week prior to initiation of treatment and the result is negative; 8. To understand and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer 2. Diagnosis of stage IV non-small cell lung cancer with brain metastases and / or bone metastases 3. Antitumor treatment, including chemotherapy, radiotherapy or targeted therapy (including and not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) or other drug clinical trials 4. No EGFR sensitive mutation (19-DEL / L858R); 5. After the treatment of PET-CT examinationto > stage of IIIA ; 6. Surgery after targeted therapy did not meet the criteria for radical resection of lung cancer (in accordance with the Ministry of Health, "primary lung cancer diagnosis and treatment norms" 2015 definition: failed anatomical lobectomy (such as pulmonary wedge resection, etc.); failure to line system Lymph node dissection (not reached the standard lymph node dissection requirements at least 6 groups, including three groups of lungs, mediastinal group 3)). 7. There was no sensitive mutation (19-DEL / L858R) or resistant mutation in the EGFR gene of the tumor after surgery. 8. Pregnancy or lactation; 9. the condition of each organ system; 1) intermittent lung disease, drug-induced interstitial disease, radiation therapy requiring hormone therapy, or any clinically active interstitial lung disease with clinical evidence; 2) Evidence of the existence of a serious or uncontrollable systemic disease (eg, unstable or compensatory breathing, heart, liver and kidney disease) according to the investigator; 3) any unstable systemic disease (including active infection, grade III hypertension, unstable angina, congestive heart failure, liver and kidney or metabolic diseases); 4) can not accept oral medication, need intravenous high energy nutrition, before the impact of the absorption of surgery or active gastrointestinal ulcers in patients; 5) have a clear history of neurological or mental disorders, including epilepsy or dementia; 10. Functional levels of various organ lesions in patients; 1) Blood: Absolute neutrophil count (ANC) normal upper limit of 1.5 times; 3) kidney: serum creatinine> normal standard value of 1.25 times; 4) Any evidence of other diseases, neurological or metabolic disorders, physical examinations or laboratory findings reasonably suspects that there is a risk of illness or the presence of a counterintelligence of the use of the relevant drug or the possibility of a subject at a high risk of treatment-related complications ; 11. Allergy to EGFR-TKI related drugs; 12. The investigators believe that the subject may not be able to complete the study or may not be able to comply with the requirements of this study (due to management reasons or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactYongde Liao
Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Outcome results
None listed