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Not yet recruiting 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

— Observational Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sampling.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

  • Other blood sampling
    blood sampling

Primary outcome measures

  • Area under the ROC curve (AUC) of neutrophil DNA methylation profiles for predicting histologic response [Time frame: 6 Months after inclusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier

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. PMID 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 PMID 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 Thora PMID 28483607

Identifiers

NCT: NCT06974097 · RECHMPL24_0275

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗