Clinical trial · Observational
A Study for Identification of Predictive Immune Biomarker in Peripheral Blood for Nivolumab Therapy in NSCLC Patients
- 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 study aimed to elucidate predictive immune related biomarker to the responsiveness to the PD-1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC patients during nivolumab treatment. Hypothesis that The ratio of MDSC after 1st or 2nd cycle can predict the response to nivolumab in NSCLC patients earlier than the tumor assessment by imaging scan. The primary objective is to determine whether myeloid-derived suppressor cell (MDSC) ratio after 1st or 2nd cycle of nivolumab can be accurate predictive biomarkers of nivolumab in advanced NSCLC.
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 |
|---|---|---|---|
| Non -Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nivolumab | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- MDSC markers
- timeFrame
- change from baseline blood biomarker at 6 weeks or progression
- description
- CD11b, Gr11b,
- measure
- Changes of Tregs markers
- timeFrame
- A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)
- description
- FOXP3, CD25, CD127, CD45RA
- measure
- T cell/NK cell marker
- timeFrame
- A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)
- description
- CD3, CD4, CD8, FoxP3, CD56
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥ 18 years old. * Histologically confirmed advanced NSCLC * Metastatic or recurrent stage * Failed to previous platinum based chemotherapy * Performance status of Eastern Cooperative Oncology Group 0 to 1. * Adequate organ function * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Exclusion Criteria: * Symptomatic or uncontrolled brain metastasis * History of autoimmune disease * Other primary cancer within 3 years
References
Publications (1)
- DERIVEDKim CG, Hong MH, Kim KH, Seo IH, Ahn BC, Pyo KH, Synn CB, Yoon HI, Shim HS, Lee YI, Choi SJ, Lee YJ, Kim EJ, Kim Y, Kwak JE, Jung J, Park SH, Paik S, Shin EC, Kim HR. Dynamic changes in circulating PD-1+CD8+ T lymphocytes for predicting treatment response to PD-1 blockade in patients with non-small-cell lung cancer. Eur J Cancer. 2021 Jan;143:113-126. doi: 10.1016/j.ejca.2020.10.028. Epub 2020 Dec 7. PMID 33302114