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

NCT ID: NCT06974097

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-12-30

Brief Summary

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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)

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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blood sampling

blood sampling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille TRAVERT, Doctor of Medicine

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier

Locations

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CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, Cedex 5, France

Site Status

Countries

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France

Central Contacts

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Camille TRAVERT, Principal Investigator

Role: CONTACT

033 4 67 33 61 35

Anne CADENE

Role: CONTACT

0 33 4 67 33 08 14

Facility Contacts

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Camille TRAVERT

Role: primary

033467336135

References

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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.

Reference Type BACKGROUND
PMID: 31754025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29191879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28483607 (View on PubMed)

Other Identifiers

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RECHMPL24_0275

Identifier Type: -

Identifier Source: org_study_id

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