Non-small cell lung cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range 18-75 years. 2. ECOG status score of 0-1. 3. Patient diagnosed with Multiple Primary Lung Cancer (MPLC) (based on M-M/ACCP clinical criteria), identified on preoperative chest CT scan (1mm layer thickness) evaluation; patient with resectable multiple lung cancer in both lungs, with R0 resection of the primary lesion on one side (lesion >=1cm, postoperative pathology stage Ib or higher), and confirmed of EGFR gene sensitive mutations (19Del, and or 21L858R mutations). 4. Patient should have at least one residual nodules in the contralateral lung that cannot be resected at the same time as the main lesion and are suspected to be malignant, solid or ground-glass or mixed density nodules (>=1cm, RECIST1.1), which exist for a long time after follow-up. The possibility of malignity is considered high clinically, and wedge resection, segmental resection or lobectomy of the lung should be performed. Confirmed by radiologist and thoracic surgeon. 5. Estimated lifetime is greater than 12 weeks. 6. Patients have not received systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer. 7. Patients who have received radiotherapy could be enrolled, but the radiotherapy area had to be less than 25% of the bone marrow area (Cristy and Eckerman, 1987) and no total pelvic or chest irradiation were used; Prior radiotherapy must have ended at least 4 weeks before enrollment, and acute radiation toxicity must have recovered; 8. Patients have adequate baseline organ and marrow function: (1) Hematological parameters: absolute neutrophil count >= 1.75 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 9.0 g/dL (can be maintained by transfusion); (2) Liver function criteria: total bilirubin = 66ml/min. 9. Women of childbearing age must have a negative urine pregnancy test within 7 days prior to initial treatment and are not breastfeeding, and men must agree to use appropriate methods of contraception or have been surgically sterilized during the trial and after dosing with trial drug. 10. Able to comply with the requirements of the research protocol and follow-up procedures. 11. Sign written informed consent prior to implementing any trial-related procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with unresectable or distant metastasis of lung cancer, such as multiple metastases to pleura or pericardium, etc. 2. Subjects who have received previous chemotherapy or systemic anti-tumor therapy (including targeted therapy, immunotherapy, etc.). 3. If subjects suffer from other malignant tumors in the past 5 years, excluding cured basal cell carcinoma, cervical carcinoma in situ, and surgically treated localized prostate cancer or surgically removed ductal carcinoma in situ. 4. Major heart disease such as acute myocardial infarction within 6 months. 5. Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence of idiopathic pulmonary fibrosis on baseline CT scan. 6. Large pleural effusion or pericardial effusion. 7. Any unstable systemic disease (including active infection, poorly controlled high blood pressure, unstable angina, congestive heart failure, liver, kidney or metabolic disease). 8. Any significant ocular abnormality, particularly severe dry eye syndrome, keratoconjunctivitis sicca, severe exposure keratitis, or other condition that may increase epithelial damage. 9. Subjects who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery affecting absorption, active gastrointestinal ulcer, chronic diarrhea. 10. Subjects with any clinical evidence of moderate to severe chronic obstructive pulmonary disease (COPD) (High-risk factors of COPD, pulmonary function test FEV1/FVC<70%, FEV1<80% predicted value, with or without symptoms of chronic cough, sputum, dyspnea) and other active lung disease as judged by the investigator. 11. History of hypersensitivity reactions to active or inactive excipients of Furmonertinib or drugs with similar chemical structure or class to Furmonertinib1 12. In the opinion of the investigator, the subject may not be able to complete the study or may not be able to comply with the requirements of the study (due to administrative or other reasons). 13. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Pathological complete response,pCR;Major pathologic response,MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Event free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactNi Bin
Outcome results
None listed