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

NCT06974097 | Not Yet Recruiting

• 1 other identifier: RECHMPL24_0275
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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)

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  6 Months after inclusion

Interventions

blood sampling OTHER

blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnant women

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, Cedex 5, 34295, France

Location

Related Publications (3)

• 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.

  PMID: 31754025 BACKGROUND

• 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.

  PMID: 29191879 BACKGROUND

• 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.

  PMID: 28483607 BACKGROUND

Related Links

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Camille TRAVERT, Doctor of Medicine

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille TRAVERT, Principal Investigator

CONTACT

033 4 67 33 61 35; camille.travert@chu-montpellier.fr

Anne CADENE

CONTACT

0 33 4 67 33 08 14; a-cadene@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 28, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)