advanced Non-Small Cell Lung Cancer
Conditions
Interventions
case series:N/A
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years; 2) Histologically confirmed stage IV non-small cell lung cancer; 3) Subjects have chest lesions that can be measured according to RECIST1.1, and no atelectasis; 4) Avoid anti-PD-1 / PD-L1 treatment 1 month before and after radiotherapy; 5) ECOG score is 0~1; Life expectancy >= 12 weeks; 6) Subjects must have adequate organ function; 7) Fertile women must undergo a negative serum pregnancy test 7 days before radiotherapy. The man and his partner should agree to use effective contraception for 3 months from the date of signing ICF until the end of radiotherapy; 8) Subjects must voluntarily participate in this study and sign an informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1) Small cell lung cancer or components of small cell lung cancer were identified histologically; 2) EGFR, ALK/ROS1 mutations; 3) Patients with brain metastasis; 4) With a history of other primary tumors; With a history of allotransplantation; 5) Major surgery excluding diagnostic biopsy was performed within 4 weeks before radiotherapy; 6) Uncontrolled hypertension, uncontrolled arrhythmias, symptomatic congestive heart failure, patients with unstable angina or new angina, active interstitial lung disease, severe gastrointestinal diseases with diarrhoea, and active infections (including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus); 7) Have received any antibody/drug (including PD-1, PD-L1, CTLA4, TIM3, LAG3, etc.) targeting co-regulatory proteins of T cells (immune checkpoint); 8) Have interstitial lung disease (ILD), or have a previous history of interstitial lung disease and require hormone therapy; 9) Previous history of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonia, mechanical pneumonia (such as bronchiolitis obliterans), and idiopathic pneumonia; Or subjects with chest CT evidence of active pneumonia during screening; 10) Received live vaccination within 28 days before radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| six-month progression-free survival;Incidence of radiation pneumonia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Remission Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactXiaomei Gong
Shanghai Pulmonary Hospital
Outcome results
None listed