Lung cancer
Conditions
Interventions
Observation Group for Lung Cancer Treatment:None
Sponsors
Shanghai pulmonary hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participated in this study and signed the written informed consent approved by the ethics committee. 2. At the time of enrollment, the age was >= 18 years old, and gender was not restricted. 3. Histologically or cytologically confirmed NSCLC that was classified as locally advanced (IIIB/IIIC stage) or metastatic (IV stage) according to the 9th edition of the International Association for the Study of Lung Cancer's TNM staging system, and the investigator judged that the patient was not suitable for radical surgery or concurrent radiotherapy and chemotherapy. 4. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score was 0-2. 5. Expected to survive for more than 3 months. 6. Tumor tissue with high PD-L1 expression (defined as tumor proportion score [TPS] = 50%) was detected by a central laboratory or research center-approved and qualified pathology department. If not detected, the subject must provide tumor tissue samples (archived or freshly obtained) diagnosed as locally advanced or metastatic tumors at the time or after, approximately 10-15 samples for PD-L1 expression detection. 7. No known EGFR sensitive mutations or ALK gene fusion. For non-squamous cell carcinoma patients, the EGFR and ALK test results must be available; for squamous cell carcinoma patients, it is recommended to conduct the test, and if not conducted, it is based on clinical practice judgment. 8. No systemic anti-tumor treatment targeting locally advanced or metastatic NSCLC had been received previously. For patients who had received neoadjuvant/adoptive treatment for the purpose of radical surgery previously, if the last treatment was more than 6 months after recurrence/metastasis, they could be enrolled. 9. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there was at least one measurable lesion at baseline. 10. The attending physician has decided to use everolizumab monotherapy as the first-line treatment for this patient. 11. The investigator judged based on clinical practice that the patient's organ functional reserve could tolerate the treatment in the study stage. 12. Unsterilized male subjects and fertile female subjects agreed to take effective contraceptive measures from the start of screening to at least 120 days after the end of the last medication.
Exclusion criteria
Exclusion criteria: 1. The histological diagnosis includes small cell carcinoma or neuroendocrine carcinoma components. 2. Participating in another interventional clinical study. 3. Known EGFR-sensitive mutations or ALK fusion positive or BRAF V600E mutation or ROS1 fusion positive non-small cell lung cancer. 4. Having a severe bleeding tendency or history of coagulation dysfunction; within 1 month before the first administration, there were significant clinical symptoms of bleeding, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing or expectoration of = 1 teaspoon of blood or small blood clots or coughing up blood without sputum, allowing those with blood in sputum to be enrolled), nasal bleeding (excluding epistaxis bleeding and retrograde nasal blood), and imaging during the screening period showed that the tumor surrounded important blood vessels or had obvious necrosis and cavities, and the investigator determined that entering the study would cause a bleeding risk; central type, with cavities, squamous NSCLC, and the investigator judged that the bleeding risk was high. 5. Tumor invasion of surrounding important organs and blood vessels (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or risk of esophageal-tracheal fistula or esophageal pleural fistula; tumor mediastinal lymph node metastasis invading the trachea, main bronchus. 6. Within 6 months before the first administration, any arterial thromboembolic event, NCI CTCAE 6.0 version grade 3 and above venous thromboembolic events, transient cerebral ischemia attack, cerebrovascular accident, hypertension crisis or hypertensive encephalopathy; currently existing hypertension and after oral antihypertensive drug treatment, systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg. 7. Previously received systemic immunotherapy such as immune checkpoint inhibitors (such as PD-1/PD-L1, CTLA-4, TIGIT or LAG3 inhibitors, etc.) or immune checkpoint agonists (such as CD40, CD137, ICOS, OX40, GITR antibodies, etc.), cell immunotherapy, etc. targeting the tumor immune escape mechanism, or previously received systemic anti-angiogenic treatment (including but not limited to bevacizumab and its biological analogues, ramucirumab, Endostar, Apatinib, Anlotinib, etc.). 8. Presence of active central nervous system (CNS) metastatic lesions and after targeted treatment (such as surgery, radiotherapy) there is no significant improvement in symptoms. Untreated, asymptomatic brain metastasis subjects (i.e., without neurological symptoms, no need for corticosteroids, no obvious peritumoral edema) can be enrolled. 9. Brainstem, meningeal metastasis, spinal cord metastasis or compression. 10. Previous history of myocarditis, cardiomyopathy, malignant arrhythmia. Within 12 months before the first administration, there was unstable angina pectoris, myocardial infarction, congestive heart failure or vascular disease (such as aortic aneurysm with rupture risk), or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial infarction or ischemia). 11. History of immunodeficiency disease; positive HIV antibody test; currently using long-term systemic corticosteroids. 12. Known active tuberculosis (TB), subjects suspected of having active TB, need clinical examination to exclude; known active syphilis infection. 13. Known history of allogeneic organ transplantation and allog
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The median progression-free survival in the real world; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Real world objective response rate;Real world disease control rate;Real world duration of response;Real world Time to Response; | — |
Countries
China
Contacts
Public ContactChunxia Su
shanghai pulmonary hospital
Outcome results
None listed