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Not yet recruitingNCT06974097NEO-TANUpdated Jul 8, 2025

Tumor Associated Neutrophils as a Biomarker of Chemo-immunotherapy Response in Locally Advanced Non-small Cell Lung Cancer : a Model Based on Neoadjuvant Strategy

An observational study in Non-Small Cell Lung Cancer, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
72
Ages
18 Years and older
Sex
All
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Study summary

evaluate the predictive value of circulating neutrophil DNA methylation profiles, identified from the ALCINA 2 cohort, on pre-treatment blood samples (T0), for the histological response to neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (NSCLC)

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Conditions studied

  • Non-Small Cell Lung Cancer
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In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 72 is below the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged 18 years, older with resectable, locally advanced non-small cell lung cancer (NSCLC) at high risk of recurrence, eligible for neoadjuvant chemo-immunotherapy

Inclusion criteria

  • Age ≥ 18 years.
  • Resectable non-small cell lung cancer (NSCLC), stage IIA to IIIB.
  • Lymph node status obtained by Positron Emission Tomoscintigraphy (PET)-scanner, confirmation of lymph node status by optional histological sampling (mediastinoscopy, thoracoscopy, echo-endoscopy).
  • No secondary lesions in the cerebrum or extra-cerebrum confirmed on brain MRI, PET scanner +/- injected cerebro-thoraco-abdomino-pelvic scanner.
  • Neoadjuvant immunochemotherapy strategy validated by a multidisciplinary consultation meeting (RCP) prior to the start of treatment.
  • Lung function compatible with thoracic surgery, patient meets surgical and anesthetic criteria for operability
  • Measurable disease according to RECIST criteria version 1.1

Exclusion criteria

Exclusion Criteria:

  • Previous systemic treatment for the same CBNPC.
  • Diagnosis of another solid tumor within the last 3 years, ‡ excluding non melanoma cutaneous and cervical carcinomas .
  • Contraindication to immunotherapy.
  • Non-objection to participate in research not collected.
  • Patients unable to read and/or write.
  • Inability to monitor patient during study period
  • Persons unable to express their consent.
  • Not affiliated to a social security scheme.
  • Persons under court protection.
  • Persons participating in another research study with an ongoing exclusion period.
  • Pregnant women
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
72 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherblood sampling

    blood sampling

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What researchers measure

Primary outcomes

  1. Area under the ROC curve (AUC) of neutrophil DNA methylation profiles for predicting histologic response

    Time frame: 6 Months after inclusion

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Study locations

1 site
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References and documents

Publications

  • Mistry P, Nakabo S, O'Neil L, Goel RR, Jiang K, Carmona-Rivera C, Gupta S, Chan DW, Carlucci PM, Wang X, Naz F, Manna Z, Dey A, Mehta NN, Hasni S, Dell'Orso S, Gutierrez-Cruz G, Sun HW, Kaplan MJ. Transcriptomic, epigenetic, and functional analyses implicate neutrophil diversity in the pathogenesis of systemic lupus erythematosus. Proc Natl Acad Sci U S A. 2019 Dec 10;116(50):25222-25228. doi: 10.1073/pnas.1908576116. Epub 2019 Nov 21. PubMed 31754025 ↗
  • Engblom C, Pfirschke C, Zilionis R, Da Silva Martins J, Bos SA, Courties G, Rickelt S, Severe N, Baryawno N, Faget J, Savova V, Zemmour D, Kline J, Siwicki M, Garris C, Pucci F, Liao HW, Lin YJ, Newton A, Yaghi OK, Iwamoto Y, Tricot B, Wojtkiewicz GR, Nahrendorf M, Cortez-Retamozo V, Meylan E, Hynes RO, Demay M, Klein A, Bredella MA, Scadden DT, Weissleder R, Pittet MJ. Osteoblasts remotely supply lung tumors with cancer-promoting SiglecFhigh neutrophils. Science. 2017 Dec 1;358(6367):eaal5081. doi: 10.1126/science.aal5081. PubMed 29191879 ↗
  • Akbay EA, Koyama S, Liu Y, Dries R, Bufe LE, Silkes M, Alam MM, Magee DM, Jones R, Jinushi M, Kulkarni M, Carretero J, Wang X, Warner-Hatten T, Cavanaugh JD, Osa A, Kumanogoh A, Freeman GJ, Awad MM, Christiani DC, Bueno R, Hammerman PS, Dranoff G, Wong KK. Interleukin-17A Promotes Lung Tumor Progression through Neutrophil Attraction to Tumor Sites and Mediating Resistance to PD-1 Blockade. J Thorac Oncol. 2017 Aug;12(8):1268-1279. doi: 10.1016/j.jtho.2017.04.017. Epub 2017 May 6. PubMed 28483607 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06974097
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 15, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 28, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Jul 8, 2025

Study contacts

Camille TRAVERT, Principal Investigator
Contact
camille.travert@chu-montpellier.fr
033 4 67 33 61 35
Anne CADENE
Contact
a-cadene@chu-montpellier.fr
0 33 4 67 33 08 14
Camille TRAVERT, Doctor of Medicine
principal investigator · CHU de Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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