TUMOR ASSOCIATED NEUTROPHILS AS A BIOMARKER OF CHEMO-IMMUNOTHERAPY RESPONSE IN LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER: a Model Based on NEOADJUVANT STRATEGY

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT06974097
• Lead Sponsor: University Hospital, Montpellier

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-06-01
• Primary Completion: 2028-07-28
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the ROC curve (AUC) of neutrophil DNA methylation profiles for predicting histologic response	6 Months after inclusion

Trial Locations

Locations (1)

CHU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, Cedex 5, France