Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer (MWA)
Advanced Non Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, microwave ablation, epidermal growth factor receptor, progression free survival, overall survival
Eligibility Criteria
Inclusion Criteria:
- Pathologically verified non-small-cell lung cancer;
- Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ;
- EGFR Exon 19del or Exon 21 L858R mutations;
- No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ;
- ECOG PS 0-1;
- Anticipated survival time ≥3 months;
- At least one measurable lesions (according to RECIST 1.1, CT scan length ≥10mm, CT scan short diameter ≥15mm) except the ablation lesions (primary lesion or the largest recurrent lesion) ;
- Asymptomatic brain metastasis;
- The routine laboratory examination was normal (blood routine, liver and kidney function, blood coagulation function, etc The standard of blood routine examination should be met (No blood transfusion and blood products within 14 days) ; ANC≥1.5×109/L; PLT ≥80×109/L. B. Biochemical examination should meet the following criteria: TBIL≤ 1.5 ULN; ALT, Ast ≤ 2.5 ULN).
- Adequate tissue specimens for further analysis.
- Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during and within 1 month after the end of the study period; The serum or urine HCG test must be negative within 72 hours before admission to the study, and must be non-lactation period; (12)18-80 years old;
(13)Patients signed informed consent;
Exclusion Criteria:
- Mixed lung cancer including neuroendocrine or small-cell lung cancer;
- Multiprimary tumors during the past 5 years;
- Uncontrolled pleural or pericardial effusion;
- Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung;
- A severe infection (CTCAE > 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization;
- baseline chest radiographic examination revealed active pulmonary inflammation.
- The patients experienced acute cardiac cerebrovascular disease such as acute cerebral infarction and acute coronary syndrome within 1 month, (8) The cardiovascular clinical symptoms or diseases were not well controlled, including the following cases: There is local active Ulcer Focus, and stool occult blood {(+ +) can not be included in the group } ; within 2 months, there are black stool, hematemesis history;
- Abnormal coagulation function with bleeding tendency;
- Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (Hepatitis B reference: HBV DNA test above the normal limit; Hepatitis C reference: HCV virus or RNA test above the normal limit) ;
- Patients with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder;
Sites / Locations
- Xin Ye
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Almonertinib plus Microwave ablation group
Almonertinib group
Patients in the group were treated with both targeted therapy and microwave ablation. Patients were treated with Almonertinib with the dose of 110mg once daily firstly. When the best response achieved, microwave ablation was conducted in the primary tumors, and then followed by Almonertinib treatments.
Patients in the group were treated with Almonertinib with the dose of 110mg once daily until disease progression, death or intolerable adverse events.