Clinical trial · Observational
Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis
NEUTROFLOW: Development and Validation of a Pan-cancer Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis of Blood Samples
NCT07246759CI-TRIAL-00097812NEUTROFLOWnot yet recruitingClinicalTrials.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 NeutroFlow study is a multi-center clinical trial designed to develop a computational model that converts flow cytometry results into a prediction of clinical benefit. The study analyzes Ly6Ehi neutrophils in biological samples from patients treated with immune checkpoint inhibitors to evaluate their likelihood of benefiting from treatment. Blood samples are collected prior to treatment and used to support the ongoing development of the algorithm.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| RCC, Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Triple Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Patients with stage IV or stage III unresectable non-small cell lung cancer (NSCLC)
- description
- Patients with stage IV or stage III unresectable non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors as a first-line treatment
- interventionNames
- Other: Blood sample collection
- label
- Patients with stage IV or stage IIIb-d malignant melanoma
- description
- Patients with stage IV or stage IIIb-d malignant melanoma treated with immune checkpoint inhibitors as a first-line treatment
- interventionNames
- Other: Blood sample collection
- label
- Patients with stage IV head and neck squamous cell carcinoma (HNSCC)
- description
- Patients with stage IV head and neck squamous cell carcinoma (HNSCC) treated with immune checkpoint inhibitors as a first-line treatment
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: • Patients newly diagnosed with advanced-stage/metastatic NSCLC, melanoma, HNSCC, RCC, or TNBC, who are due to receive first-line treatment with a PD-(L)1 inhibitor, either as monotherapy or in combination with other agents, according to current standard-of-care regimens, including (but not limited to) the following approved options: NSCLC. Monotherapy: Pembrolizumab, Atezolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy; Nivolumab + Ipilimumab; Cemiplimab + chemotherapy; Atezolizumab + chemotherapy + Bevacizumab. Melanoma. Monotherapy: Nivolumab, Pembrolizumab. Combination: Nivolumab + Ipilimumab; Nivolumab + Relatlimab. HNSCC. Monotherapy: Pembrolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy. RCC. Combination only: Nivolumab + Ipilimumab; Nivolumab + Cabozantinib; Pembrolizumab + Lenvatinib or Axitinib; Avelumab + Axitinib. TNBC. Combination only: Pembrolizumab + chemotherapy. * Male or female aged at least 18 years * ECOG PS: 0/1-2 * Normal hematologic, renal and liver function: Absolute neutrophil count \> 1500/mm³ Platelets \> 100,000/mm³ Hemoglobin \> 9 g/dL Creatinine concentration ≤ 1.4 mg/dL, or creatinine clearance \> 40 mL/min, Total bilirubin \< 1.5 mg/dL ALT + AST levels ≤ 3 times above the upper normal limit Exclusion Criteria: * Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of the first dose of treatment. * For NSCLC: presence of activating EGFR, ALK, ROS1, RET, NTRK alterations linked to an approved first-line targeted drug.
References
Publications (8)
- BACKGROUNDAlturki NA. Review of the Immune Checkpoint Inhibitors in the Context of Cancer Treatment. J Clin Med. 2023 Jun 27;12(13):4301. doi: 10.3390/jcm12134301. PMID 37445336
- BACKGROUNDMan J, Millican J, Mulvey A, Gebski V, Hui R. Response Rate and Survival at Key Timepoints With PD-1 Blockade vs Chemotherapy in PD-L1 Subgroups: Meta-Analysis of Metastatic NSCLC Trials. JNCI Cancer Spectr. 2021 Jan 27;5(3):pkab012. doi: 10.1093/jncics/pkab012. eCollection 2021 Jun. PMID 34084999
- BACKGROUNDMartins F, Sofiya L, Sykiotis GP, Lamine F, Maillard M, Fraga M, Shabafrouz K, Ribi C, Cairoli A, Guex-Crosier Y, Kuntzer T, Michielin O, Peters S, Coukos G, Spertini F, Thompson JA, Obeid M. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol. 2019 Sep;16(9):563-580. doi: 10.1038/s41571-019-0218-0. PMID 31092901
- BACKGROUNDHurwitz JT, Vaffis S, Grizzle AJ, Nielsen S, Dodson A, Parry S. Cost-Effectiveness of PD-L1 Testing in Non-Small Cell Lung Cancer (NSCLC) Using In Vitro Diagnostic (IVD) Versus Laboratory-Developed Test (LDT). Oncol Ther. 2022 Dec;10(2):391-409. doi: 10.1007/s40487-022-00197-1. Epub 2022 May 13. PMID 35556235
- BACKGROUNDLei Y, Li X, Huang Q, Zheng X, Liu M. Progress and Challenges of Predictive Biomarkers for Immune Checkpoint Blockade. Front Oncol. 2021 Mar 11;11:617335. doi: 10.3389/fonc.2021.617335. eCollection 2021. PMID 33777757
- BACKGROUNDArora S, Velichinskii R, Lesh RW, Ali U, Kubiak M, Bansal P, Borghaei H, Edelman MJ, Boumber Y. Existing and Emerging Biomarkers for Immune Checkpoint Immunotherapy in Solid Tumors. Adv Ther. 2019 Oct;36(10):2638-2678. doi: 10.1007/s12325-019-01051-z. Epub 2019 Aug 13. PMID 31410780
- BACKGROUNDMcKean WB, Moser JC, Rimm D, Hu-Lieskovan S. Biomarkers in Precision Cancer Immunotherapy: Promise and Challenges. Am Soc Clin Oncol Educ Book. 2020 May;40:e275-e291. doi: 10.1200/EDBK_280571.