Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
General Hospital of Eastern Theater of Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 years old; 2. Understand the research procedure and content, and sign written informed consent voluntarily; 3. Histopathologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer; 4. Have at least one measurable lesion according to RECIST 1.1; 5. SD was evaluated by imaging after 4-6 cycles of first-line treatment with PD-1 inhibitor; 6. Estimated survival >=3 months; 7. The main organs function is good, that is, the relevant examination indexes within 14 days before enrollment meet the following requirements: erythropoietin >= 90 g/L (no blood transfusion within 14 days); Neutrophil count & GT; 1.5 *10^9 / L; Platelet count >= 100*10^9/L; Total bilirubin = 60 mL/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 8. Women of reproductive age subjects and male subjects whose partner is a woman of reproductive age must agree to use a highly effective method of contraception during the study period and for 180 days after the last antitumor therapy.
Exclusion criteria
Exclusion criteria: 1. Subjects with a prior history of other malignancies, except for carcinoma in situ that has achieved a complete response at least 5 years prior to screening and does not require or is expected to require other treatment during the study period; 2. Subjects with known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may be detected or treated for pulmonary toxicity and seriously affect respiratory function. These include idiopathic pulmonary fibrosis, mechanized pneumonia/bronchiolitis obliterans, etc. 3. Severe disease of heart head blood-vessel of subjects, such as NYHA standard (level III or higher), within 3 months before or for the first time to give medicine happened in myocardial infarction, or cerebrovascular accident (cerebral ischemia, symptomatic cerebral infarction, etc.), or associated with coronary artery disease, and within a month before the first delivery of instability, or arrhythmia or unstable angina Congestive heart failure outside of the above criteria, or left ventricular ejection fraction during screening. 50%, or superior vena cava syndrome with existing symptoms; 4. Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study period; 5. Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] positive and HBV-DNA >=2000 IU/ML during screening) or hepatitis C (defined as HEPATITIS C virus surface antibody [HCsAb] positive and HCVC-RNA positive during screening); 6. Local palliative radiotherapy is allowed for symptomatic metastases, but it should be completed before screening, and toxicity has been recovered, and the minimum recovery time is not required; Asymptomatic metastases, such as further growth that may lead to dysfunction or intractable pain (such as epidural bone metastases that do not present spinal cord compression temporarily), should be treated locally prior to screening, if permitted; 7. Uncontrolled medium to large pleural, peritoneal or pericardial effusion requiring repeated drainage; 8. The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse; 9. The researchers believe any other medicine, such as lung, metabolic, hormonal, or neurological disease and congenital diseases, etc.), psychosis, or social status may interfere with the subjects of rights, safety, health or ability to sign the informed consent, cooperation and participation in the study, or interfere with the study drug evaluation, read the safety or the results of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Objective response rate;Disease control rate;Duration of remission;Time-to-response;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactTangfeng Lv
General Hospital of Eastern Theater of Chinese People's Liberation Army
Outcome results
None listed