Non-Small Cell Lung Cancer
Conditions
Interventions
Observation group:This is a non-interventional observational study. No study-specific interventions are applied.
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Retrospective Cohort: Age >= 18 years, regardless of gender; Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC); Clinical stage IIIB–IV according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system; Received at least one cycle of systemic anti-tumor therapy; Complete clinical documentation available, including medical records, laboratory test results, imaging data, treatment records, and tumor response assessments. Prospective Cohort: Age >= 18 years, regardless of gender; Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; Pathologically confirmed advanced NSCLC (stage IIIB–IV) with at least one measurable lesion per RECIST v1.1 criteria; Availability of complete baseline and two peripheral blood immunological assessments during the first treatment cycle; Willingness to undergo scheduled imaging evaluations; Agreement to regular monitoring of adverse events; Provision of written informed consent (English version).
Exclusion criteria
Exclusion criteria: Retrospective Cohort: History of another primary malignancy within the past 5 years (exceptions: basal cell carcinoma of the skin or cervical carcinoma in situ, if cured >= 5 years ago); Severe cardiac, hepatic, or renal insufficiency; Pregnancy or lactation; Psychiatric disorders that impair the ability to comply with treatment; Missing key clinical data exceeding 30% of required variables. Prospective Cohort: Presence of severe comorbidities, including: Uncontrolled cardiovascular disease (New York Heart Association [NYHA] Class III–IV); Severe hepatic impairment (Child-Pugh Class C); Severe renal impairment (creatinine clearance = 5 years; Major surgery within 4 weeks prior to enrollment, or radiotherapy within 4 weeks before screening; Requirement for local anti-tumor therapies (e.g., radiotherapy, interventional ablation) after enrollment; Pregnancy or lactation; Psychiatric or cognitive impairment that precludes compliance with the study procedures; Participation in another interventional clinical trial within 30 days prior to enrollment; Poor compliance, inability to attend scheduled follow-up visits, or any condition deemed by the investigator as unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Effect Model Prediction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Reaction Model Prediction; | — |
Countries
China
Contacts
Public ContactYu Guifang
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed