non-small cell lung cancer
Conditions
Interventions
Case series:NA
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who provided written informed consent for participation in this observational study; 2. Age between 18 and 75 years (inclusive); 3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) according to standard diagnostic criteria; 4. Patients treated at Guangzhou Medical University Fifth Affiliated Hospital between 2019 and 2024; 5. Driver gene-negative tumors (confirmed absence of actionable mutations in EGFR, ALK, ROS1, and other relevant oncogenic drivers); 6. Advanced-stage disease (stage IIIB-IV according to the 8th edition of the AJCC TNM staging system); 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 8. Receipt of combination therapy with immune checkpoint inhibitors and chemotherapy, with completion of at least one treatment cycle; 9. Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Exclusion criteria
Exclusion criteria: 1. History of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ); 2. Active autoimmune diseases requiring systemic treatment or history of systemic immunosuppressive therapy; 3. Severe organ dysfunction defined as: Severe cardiac insufficiency (New York Heart Association class III-IV); Severe hepatic impairment (Child-Pugh class C); Severe renal insufficiency (estimated glomerular filtration rate 30% missing essential variables); 8. Expected poor compliance or inability to complete follow-up assessments; 9. Prior treatment with immune checkpoint inhibitors; 10. Concurrent participation in other clinical studies that might interfere with study endpoints; 11. Any condition that, in the investigator's judgment, would make participation inappropriate or unsafe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Treatment Effect Prediction (AUC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Treatment-Related Adverse Event (AE) Incidence;Adverse Reaction Prediction (AUC); | — |
Countries
China
Contacts
Public ContactGuifen Yu
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed