Non-Small Cell Lung Cancer
Conditions
Interventions
Anlotinib combined with third-generation EGFR-TKI with or without local therapy group:none
Third-generation EGFR-TKIs with or without local therapy group:none
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. The age 18-75 years old (including) between the male and female patients; 2. The histology and cytology confirmed locally advanced or metastatic NSCLC (all histologic type); 3. Tests confirmed the EGFR mutations (including 19 del and 21 L858R, not including 20 exon insert), can accept the outer court pathologic examination results; 4. If slow progression/local progression/oligo-progression occurred after first-line monotherapy with the third generation EGFR-TKIs (less than two cycles of chemotherapy were allowed), the investigator's evaluation showed that the use of the original third generation EGFR-TKIs was still beneficial (the original TKI dose remained unchanged); Note: the third generation of EGFR - TKIs treated disease control after 3 months, or clinical found slow progress, partial progress/progress of the patients. Concrete are defined as compared with the previous assessment, slightly increasing the harm to the body tumor (no worsening symptoms); Progression of non-target lesions, such as pleural effusion, or combined extracranial/intracranial progression <=5 (synchronous/sequential local treatment can be used); 5. At least one measurable target lesion within the past 3 months (according to RECIST version 1.1 criteria) 6. ECOG score: 0 to 2 points;
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. The small cell lung cancer (including small cell lung cancer and non-small cell lung cancer mixed lung cancer). 2.For the treatment of three generations of EGFR TKIs - primary drug resistance (treatment time =3 months, rapid deterioration of clinical symptoms, significant progress of target lesions and aggravation of symptoms compared with the previous evaluation). 4. Patients with a definite proprietary drug target after first-line treatment with third-generation EGFR-TKIs, such as MET amplification, C797X mutation, etc.; 5. Advances in slow progress/local/oligonucleotides progress after simultaneous or sequential use other systemic treatment of the patients, such as chemotherapy, beacizumab bead sheet resistance, etc.; 6. According to the investigator's judgment, patient compliance was poor and data was missing seriously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai East Hospital
Outcome results
None listed