Lung Cancer
Conditions
Interventions
Group 1:Ositinib combined with bevacizumab
Group 2:Ositinib
Sponsors
The First Hospital Affilated to AMU
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent has been signed and, according to the researcher's judgment, the patient is able to follow the study protocol; 2. Histology and cytology (don't accept based on sputum cytology alone) confirmed not surgical treatment of locally advanced (IIIb period, not suitable for multidisciplinary therapy), metastatic (IV) or recurrent patients with squamous cell non-small cell lung cancer; 3. Gene detection confirmed 19 exon deletion mutation (19Del), 21 exon L858R mutation or G719X, S768I, L861Q. The first-line treatment was effective, lasting for more than 6 months, and the patients were all SD in two consecutive RECIST 1.1 evaluations; 4. Aged at least 18 years old; 5. The energy status score (ECOG PS) of the eastern cancer cooperative group was 0-2 points; 6. The expected survival time greater than 12 weeks; 7. Adequate hematological function: The values of the neutrophil absolute value (ANC) greater than or equal to 1.5 x 10^9/L, and Blood platelet count greater than or equal to 80 x 10^9/L and hemoglobin greater than or equal to 9 g/dL (blood transfusion can be maintained or exceeded this level); 8. Sufficient liver function: The upper limit of normal value (ULN) for the total bilirubin <1.5x, and for patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x ULN; For patients with liver metastasis, both were <5 x ULN; 9. Adequate kidney function: The calculated value of the serum creatinine clearance rate was greater than or equal to 50mL/min, andThe results of dysmenorrhea test showed that urinary protein <2+. For patients whose urinary protein content of urine is greater than or equal to 2+ at baseline, 24-hour urine collection should be conducted and the protein content in urine within 24 hours must be less than or equal to 1 g before inclusion; 10. Within 7 days before the study treatment, the international standardized rate (INR) was no more than 1.5, and some prothrombin time (PTT or aPTT) was no more than 1.5 x ULN; 11. For the postmenopausal therapeutic induced amenorrhea (not for 12 months or more) or no sterilization (ovary removal and/or uterus) of women: agreed to during the period of treatment and at the end of the study drug to abstain from sex for at least 6 months after the treatment or use <1% failure rate in single or combined methods; 12. For men, agreed to during the period of treatment and at the end of the study drug to abstain from sex for at least 6 months after the treatment or the use of condoms combined with other contraceptive methods (< 1% failure rate) and agreed to at the same time avoid donate sperm.
Exclusion criteria
Exclusion criteria: 1. The researchers think that could significantly change the risk/benefit balance in patients with any severe or uncontrolled systemic signs of illness, including uncontrolled high blood pressure, active bleeder physique, active infections, including hepatitis b, hepatitis c and human immunodeficiency virus, or bone marrow or organ function significantly damaged, including liver and kidney damage; 2. Symptomatic central nervous system (CNS) metastasis occurred in patients within 2 weeks before enrollment, except patients without any symptoms or those with symptoms but with stable condition at least 28 days after CNS metastasis; 3. In the past, there has been a history of medical ilds, a history of radioactive pneumonia requiring steroid treatment, or clinical evidence of active ilds; 4. Meet any of the following cardiac standards: In the static state, the average correction QT interval (QTcF) > 470 ms obtained by the Fredericia formula: Various clinically significant abnormalities in cardiac rhythm, conduction, resting ECG morphology (e.g., complete left bundle branch block, third-degree block, second-degree block) Various factors that may increase the risk of prolonged QTc or arrhythmia events. At the beginning of the study, there was no recovery toxicity at CT CAE level >3; 5. Hemoptysis history (defined as single event blood loss > 2.5ml in the first 3 months); 6. Currently or recently (within 10 days of the first administration of bevacizumab), aspirin (325 mg/ d) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function are used; 7. Currently or recently (within 10 days of the first administration of bevacizumab) a full dose of oral or parenteral anticoagulant or thrombolytic for therapeutic purposes. Anticoagulants are permitted for preventive purposes; 8. A history or evidence of hereditary hemorrhagic constitutions or coagulation disorders that increase the risk of bleeding; 9. Hypertension cannot be controlled (blood pressure: systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg); 10. Severe vascular diseases (including but not limited to aneurysms requiring surgical repair or recent arterial thrombosis) were present within the first 6 months of the randomized group; 11. Unhealed wounds, active peptic ulcers, or fractures; 12. A history of abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within the first 6 months; 13. Be pregnant or lactating, or plan to be pregnant during the study period; 14. Any other trial using drugs or participating in other clinical trials was performed within 28 days before randomization; 15. Evidence exists as follows: persistent or active infections requiring intravenous antibiotics; Any other disease, nervous system or metabolic disorder; Physical examination results or laboratory results are reasonably suspected of prohibiting the use of experimental drugs or putting patients at a higher risk of treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactZhou Xiangdong
The First Hospital Affilated to AMU
Outcome results
None listed