Clinical trial · Observational
The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer
The Peripheral Blood Lymphocyte Subsets as Predicative Biomarkers Reflecting the Efficacy and Toxicity in Patients With Locally Advanced Non-small Cell Lung Cancer Received Chemoradiotherapy With or Without Immunotherapy
- 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 prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).
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 |
|---|---|---|---|
| Locally Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent or sequential chemoradiotherapy | Radiation | — | UNRESOLVED |
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- NSCLC patients received CRT plus ICIs
- description
- For it's an observational study, locally advanced NSCLC patients received CRT with induction immunotherapy or consolidation immunotherapy will be divided into the group "NSCLC patients received CRT plus ICIs".
- interventionNames
- Radiation: concurrent or sequential chemoradiotherapy
- Drug: Immunotherapy
- label
- NSCLC patients received CRT
- description
- For it's an observational study, locally advanced NSCLC patients received CRT without immunotherapy will be divided into the group "NSCLC patients received CRT".
- interventionNames
- Radiation: concurrent or sequential chemoradiotherapy
Primary outcomes (1)
- measure
- Adverse Event
- timeFrame
- AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years; ECOG score 0-2. 2. Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system. 3. Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. 4. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: 1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement. 2. Patients with other active malignancies within 5 years or at the same time. 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome). 4. History of allogeneic organ transplantation. 5. History of active primary immunodeficiency. 6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. 7. Women of child-bearing potential who are pregnant or breastfeeding. 8. The investigator judged other situations not suitable for inclusion in this study.
References
Publications (0)
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