Non-small cell lung cancer
Conditions
Interventions
Furmonertinib group:Furmonertinib 160mg
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provide informed consent prior to any study of specific procedures; 2. Aged >= 18 years; 3. ECOG physical condition score was 0-1 and did not deteriorate 2 weeks prior to enrollment, and life expectancy was >=12 weeks; 4. Histological or cytological diagnosis of non-small cell lung cancer; 5. Locally advanced or metastatic non-small cell lung cancer (AJCC Version 8 TNM stage IIIB or IV) assessed by investigators as not feasible or feasible for surgical resection and not feasible or feasible for radical radiotherapy; 6. A histological or cytological report issued or approved by a tertiary Class A hospital or a qualified testing institution confirms the presence of classical EGFR mutations; 7. The patient had not received systemic antitumor therapy for advanced/metastatic non-small cell lung cancer, including standard chemotherapy, biotherapy, targeted therapy, immunotherapy, or investigational drug therapy, prior to initiation of the study drug therapy; Patients who had received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) were admitted if they had not progressed within 6 months of treatment; Patients who had received local treatment (radiotherapy or pleural perfusion) were allowed to be enrolled if the lesions within the local treatment range were non-target lesions; 8. According to RECIST1.1, the subject has at least one lesion that has not been irradiated in the past and has not received tissue biopsy during the screening period, which can be accurately measured; 9. Fertile female patients should use highly effective birth control at least 2 weeks before starting the study drug, pregnancy tests must be negative, and there must be no ongoing breastfeeding before starting the drug; 10. Male patients should be willing to use effective barrier contraception (condoms); 11. Be able to comply with the requirements of the study protocol and follow-up procedure, and receive oral medication.
Exclusion criteria
Exclusion criteria: 1. Small cell carcinoma of lung; 2. Known history of hypersensitivity to active or inactive excipients of vometinib or to drugs with structures or classes similar to the test drug; 3. Confirmed insertion mutation of EGFR exon 20; 4. There is spinal cord compression or symptomatic brain metastasis; Patients who were asymptomatic, stable, and did not need steroid treatment for 14 days or more before the start of study therapy were excluded. Patients who had received local radiotherapy for brain metastases could be enrolled only after the end of radiotherapy and the symptoms of brain metastases were stable for 14 days or more; 5. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow study drugs, or previous colorectal cancer resection that prevent full absorption of vometinib; 6. Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to protocol compliance, or active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) (including any patients receiving intravenous treatment for infections; Active hepatitis B infection includes at least all patients who are serologically positive for hepatitis B surface antigen); 7. History of interstitial lung disease, drug-induced interstitial lung disease, prior history of radiation pneumonia requiring steroid treatment, or any evidence of active interstitial lung disease; 8. Lack of adequate bone marrow reserves or organ function (including bone marrow, liver, kidney, blood clotting, heart function); 9. Pregnancy or lactation; 10. Patients determined by the investigator to be unable to participate in the study, such as patients with a high probability of failing to comply with the study regulations, constraints and requirements; Or other conditions at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depth of target lesion remission in 1/2/3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimal target lesion remission depth;Objective response rate;Disease control rate;Progression free survival;Security;Tolerance; | — |
Countries
China
Contacts
Public ContactZhang Lu
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed