Lung cancer
Conditions
Interventions
Group A:Anlotinib combined with dactinib
Group B:Anlotinib combined with ametinib
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participated in the study and signed informed consent; 2.Age > 18 years old, both male and female; 3.Patients with locally Advanced or metastatic (stage III B, III C or IV) NSCLC confirmed by histology or cytology, and EGFR 19del and / or 21 L858R mutations were detected by NGS,and asymptomatic brain metastases can be enrolled; 4.According to the evaluation criteria of solid tumor efficacy (RECIST1.1), one measurable lesion can be used as the target lesion at least; 5.PS score 0~3; 6.Expected survival time>= 3 months; 7.Patients who had not previously received systematic antitumor therapy, including radiotherapy and chemotherapy, targeted and immunotherapy.
Exclusion criteria
Exclusion criteria: 1.NSCLC with other pathological components; 2.Before enrollment, patients received systematic chemotherapy, radiotherapy, EGFR-Tkis, anti-angiogenesis and immunotherapy for advanced NSCLC; 3.Poor blood pressure control (systolic blood pressure >=150mmHg, diastolic blood pressure >=100mmHg), abnormal urinary protein can not be controlled; 4.Imaging showed that the tumor invaded important blood vessels, or the researcher judged that the tumor was very likely to invade important blood vessels during the follow-up study, resulting in fatal massive bleeding; 5.Patients with venous thrombotic events, such as cerebrovascular accidents, deep venous thrombosis and pulmonary embolism; 6.According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family and social factors, which will affect the safety of the subject or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactZhang Jianqing
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed