Late non-squamous NSCLC
Conditions
Interventions
Ochinib:Oral Oxytinib 80mg daily
Ochtinib combined with anlotinib:Daily oral administration of octatinib 80mg combined with erlotinib, erlotinib for two weeks, stop for one week
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Get informed consent. 2. Histological or cytological confirmation of advanced non-small cell lung cancer (TNMIII Phase B or IV) that cannot be operated, relapsed or metastatic, disease progression after treatment with EGFR-TKI for 1 or 2 generations. 3. The gene report confirmed the T790M mutation. 4. At least one measurable lesion (spiral CT scan with a long diameter >= 10 mm, meeting the requirements of the Standard Entity Tumor Response Assessment Criteria (RESCIST) version 1.1). 5. Eastern Tumor Cooperative Group (ECOG) Performance Status (PS): 0-2. 6. Aged 18 to 75 years (including 18 and 75 years). 7. Life expectancy >= 3 months. 8. Adequate bone marrow reserve and organ function. 9. Blood pressure is below 135 / 85mmHg. 10. Women with fertility potential must undergo a negative serum pregnancy test. Sexually active men and women who are willing to take contraception during the study (have fertility).
Exclusion criteria
Exclusion criteria: 1. There are other anti-angiogenic drug treatment history. 2. Unhealed toxicity of previous anticancer treatment (CTCAE grade 1) or surgery. 3. Symptomatic central nervous system (CNS) metastasis. 4. Uncontrolled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic >=90 mmHg after drug treatment). 5. Active uncontrolled infections, such as acute pneumonia, active hepatitis B or hepatitis C (history of previous hepatitis B, whether or not receiving medical treatment, HBV DNA >= 500 copies or >= 100 IU / ml). Hemorrhage (red blood, 1/2 teaspoon) occurred within 2 weeks of arterial thrombosis or venous thrombosis within 6 months, or evidence of thrombosis/bleeding within 2 months (although severity). A 12-month stroke or transient ischemic attack (TIA). 6. Unhealed skin lesions, surgical site, injury, severe mucosal ulcers or fractures. 7. Assessment of cardiac function: LVEF = NUMHA2. 8. Combine other malignant diseases. 9. Record medical history of neurological or psychiatric disorders, including epilepsy and dementia. 10. Recent active digestive diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, etc., intestinal perforation, intestinal fistula or other diseases can cause gastrointestinal bleeding or perforation, at the discretion of the investigator. 11. Dysphagia or known malabsorption. 12. History of organ transplantation and long-term immunosuppressive drugs. 13. Participate in a new drug clinical trial within one month or participate in the trial immediately. 14. Pregnant or lactating women. 15. A history of allergic reactions to iropinib analogs and/or pharmaceutical excipients in this study. 16. Other conditions are at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Objective Response Rate;disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactZhao Qiong
Shulan (Hangzhou) Hospital
Outcome results
None listed