lung cancer
Conditions
Interventions
NA:NA
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-75 when signing the informed consent form; 2. The patients voluntarily agreed to participate and signed an informed consent form; 3. Locally advanced or metastatic lung adenocarcinoma confirmed by histology or cytology (patients with mixed lung squamous cell carcinoma, if the adenocarcinoma content is more than 50%, the investigator will judge whether to be included in the group according to the actual situation); 4. EGFR mutation is positive; 5. There is at least one measurable lesion in intracranial that meets the RANO standard; 6. ECOG score 0-2 points; 7. The expected survival period is not less than 12 weeks; 8. The function of vital organs and bone marrow meet the following requirements: Blood routine: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet (PLT) >=100×10^9/L, hemoglobin (HGB) >=9g/dL (Note: This must be achieved without blood transfusion within 4 weeks prior to sample acquisition); Liver function: serum total bilirubin (TBIL) =2.8g/dL; Renal function: serum creatinine (Cr)=40mL/min; 9. Women of reproductive age need to provide pregnancy test report within 3 days before the start of treatment, and the result must be negative; 10. Women of reproductive age must take effective contraception during the study and at least 120 days after the last dose of Almonertinib, at least 180 days after the last anti-angiogenesis therapy. It is recommended that take contraceptive measures at least 3 months before the study treatment is first administered. 11. Unsterilized male must take effective contraception during the study and at least 180 days after the last dose of Almonertinib and anti-angiogenesis therapy. It is recommended that take contraceptive measures at least 3 months before the study treatment is first administered.
Exclusion criteria
Exclusion criteria: 1. Patients with negative EGFR mutations; 2. Patients with metastases of meninges or spinal cord; 3. There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage (patients who do not need to drain the effusion or stop the drainage for 3 days without a significant increase in effusion can be included in the group); 4. Known uncontrollable hypertension and proteinuria; 5. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Allergic to any ingredients of Bevacizumab and Almonertinib; 7. Currently suffering from severe interstitial lung disease; 8. Suffer from other uncontrolled serious diseases, including but not limited to: (1)Severe infections that are in the active phase or poorly clinically controlled; (2)People infected with HIV (HIV antibody positive); (3)Suffer from acute or chronic active hepatitis B (HBsAg positive and HBVDNA>1*103/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA>15IU/ml); (4)Active tuberculosis, etc.; (5)Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia; (6)Uncontrolled arterial hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg); (7)Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular disorders or transient ischemic attack, occurred within 6 months before being selected for treatment; (8)Diseases that require the use of Warfarin (coumarin) anticoagulant treatment; (9)Uncontrolled hypercalcemia (calcium ion>1.5 mmol/L or calcium>12 mg/dL or corrected serum calcium>ULN), or symptomatic hypercalcemia that requires continued diphosphate treatment; (10)With other malignant tumors (except those that have been cured, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.); (11)Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may cause the following results: increase the risk related to study participation or study drug administration, or interfere with the interpretation of research results, and the patient will be classified as ineligible to participate in the study at the discretion of the investigator. 9. Pregnant or lactating women; 10. Inject anti-infective vaccines (such as influenza virus vaccine, human papilloma virus vaccine) within 4 weeks before study drug treatment. It is forbidden to use other vaccines during the treatment period, except for inactive vaccines; 11. Major surgery has been performed within 4 weeks (28 days) before study drug treatment, except for diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Phase II Dose;Intracranial Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Progression-free Survival;Median Overall Survival; | — |
Countries
China
Contacts
Public ContactZhenzhou Yang
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed