Clinical trial · Observational
irAE Prediction of Anti-PD-1/L1 in Lung Cancer
Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
NCT05288569CI-TRIAL-00065411unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- occurrence of immune-related adverse event (irAE)
- timeFrame
- 12 months since immunotherapy initiation
- description
- Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 24 months since immunotherapy initiation
- description
- Patients will be followed up for 2 years to investigate Overall Survival
- measure
- Progression Free Survival.
- timeFrame
- 24 months since immunotherapy initiation
- description
- Patients will be followed up for 2 years to investigate Progression Free Survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 18-80 years of age * Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques * Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication) Exclusion Criteria: * Other cancer treatment * Other malignancies
References
Publications (1)
- BACKGROUNDYang H, Yao Z, Zhou X, Zhang W, Zhang X, Zhang F. Immune-related adverse events of checkpoint inhibitors: Insights into immunological dysregulation. Clin Immunol. 2020 Apr;213:108377. doi: 10.1016/j.clim.2020.108377. Epub 2020 Mar 2. PMID 32135278