Clinical trial NCT06974097: Tumor Associated Neutrophils as a Biomarker of Chemo-immunotherapy Response in Locally Advanced Non-small Cell Lung Cancer : a Model Based on Neoadjuvant Strategy
Official title: Tumor Associated Neutrophils as a Biomarker of Chemo-immunotherapy Response in Locally Advanced Non-small Cell Lung Cancer : a Model Based on Neoadjuvant Strategy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief 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)


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Area under the ROC curve (AUC) of neutrophil DNA methylation profiles for predicting histologic response
timeFrame: 6 Months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
state: Cedex 5
Study officials:
affiliation: CHU de Montpellier
name: Camille TRAVERT, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.