Non-small cell lung cancer
Conditions
Interventions
Case series:Nil
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged .=18 years old; 2. ECOG PS score 0-2 points; 3. Imaging and pathological tissue confirmed the diagnosis of stage IIIB-IV NSCLC (according to the 8th edition TNM staging); 4. Non-squamous cell carcinoma patients have a regular platform of genetic testing report, genetic testing confirmed no EGFR mutation and ALK rearrangement; 5. PD-L1 expression detection has been performed before the use of pembrolizumab or sintilimab treatment; 6. At least two courses of first-line treatment with pembrolizumab or sintilimab; 7. Based on RECIST 1.1 response evaluation criteria for solid tumors, at least one measurable lesion; 8. Before the first use of pembrolizumab or sintilimab treatment to improve the routine baseline examination (including blood routine, biochemistry, chest CT, thyroid panel, pituitary panel, chest pain panel, myocardial enzyme spectrum, ECG, etc.). 9. Before each cycle of treatment, blood routine, biochemistry (liver and kidney function, electrolytes, blood glucose, blood lipids), respiratory tumor indicators (CEA, CA125, CYFRA211, CA724, NSE, etc.); 10. Periodic examination of thyroid function test, pituitary test, plasma adrenocorticotropic hormone determination, serum cortisol determination, chest pain set, myocardial enzyme spectrum; 11. Regular chest CT imaging evaluation; 12. Perfect abdominal CT (or abdominal and bilateral renal adrenal B ultrasound), cranial enhanced MRI, bone ECT, PET-CT, etc.
Exclusion criteria
Exclusion criteria: 1. Patients with malignant tumors other than NSCLC, but expected to be curable tumors and tumors with negligible risk of metastasis and death can be enrolled; 2. Pregnant or lactating women; 3. Known to have human immunodeficiency virus (HIV) infection or a history of organ transplantation; 4. Patients with active autoimmune diseases, requiring systemic treatment (use of corticosteroids, immunosuppressive agents, etc.); replacement therapy (such as thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not regarded as a form of systemic treatment; 5. Patients used two or more different PD-1 inhibitors during treatment; 6. Patients with evidence of interstitial pneumonia before the use of PD-1 inhibitors; 7. Patients with severe liver and kidney function damage, cardiac insufficiency before the use of PD-1 inhibitors; 8. Patients with poor treatment compliance, incomplete medical records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactJiang Junhong
The First Affiliated Hospital of Soochow University
Outcome results
None listed