Clinical trial · Observational
18F-FDG PET/CT to Evaluate pD-1 Monoclonal Antibody With First-line Chemotherapy in Advanced NSCLC
A Prospective, Single-arm, Observational Clinical Study Based on 18F-FDG PET/CT to Evaluate the True Efficacy and Immune Response of PD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer
- 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)
This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of 18F-FDG PET/CT for diagnosis the true efficacy and immune response of Non-small Cell Lung Cancer
- timeFrame
- 2 years
- description
- PET/MR results will be compared with histopathological, clinical, laboratory, radiological evidence, and follow-up results.
Secondary outcomes (1)
- measure
- Change after treatment
- timeFrame
- 2 years
- description
- For patient after treatment, change of PET scan and clinical/radiological/histopathological indices.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (age 18 or above), gender unlimited; * Pathological diagnosis of non-small cell lung cancer stage IIIB or above; * Agree to carry out the standard first-line chemotherapy combined with immunosuppression established in this study; * Consent to 18F-FDG PET/CT imaging and related laboratory examination before and during treatment; * The patients themselves or their legal representatives are aware of this study and can sign the informed consent. Exclusion Criteria: * Acute systemic diseases and electrolyte disturbances; * Pregnant or lactating women; * The patient or his legal representative is unable or unwilling to sign the informed consent.
References
Publications (0)
Data not yet available