Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer

NCT ID: NCT02551211

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-14
• Study Completion Date: 2020-02-10

Brief Summary

With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would allow physicians to monitor the immune status of their patient's tumor and though to evaluate the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such blood marker has been validated so far. The LYMPHOLUNG study investigate the concordance between blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC. By the use of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The prognostic value of the circulating and intra-tumoral T regulator over total lymphocytes ratio for 2-year recurrence-free survival will also be addressed.

Conditions

Resectable Non-small Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC

Study Groups

Patients with resectable non-small cell lung cancer

Group Type: EXPERIMENTAL

blood drawn

Intervention Type: PROCEDURE

blood drawn

surgical resection of cancer

Intervention Type: PROCEDURE

Interventions

blood drawn

blood drawn

Intervention Type: PROCEDURE

surgical resection of cancer

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Men and women over 18 years of age
• Histologically- or cytologically- confirmed non-small cell lung cancer diagnostic
• Stage I, II or IIIA NSCLC (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). Staging must have included an abdominal and thoracic CTscan, a CTscan or MRI of the brain and a 18FDG PETscan
• Subjects for whom a surgical resection is indicated
• Signed written informed consent

Exclusion Criteria

• - previous, ongoing or planned neo-adjuvant treatment (chemotherapy, targeted therapy, immunotherapy or radiotherapy)
• contraindications to general anesthesia
• contraindication to the planned surgical resection
• history of immunosuppressive disorder
• known history of testing positive for human immunodeficiency virus
• subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 30 days of randomization.
• clinical suspicion of active infection (either acute or chronic)
• severe (hemoglobin < 8.0 g/dL) or symptomatic anemia
• women of childbearing potential must have a negative urine pregnancy test
• women must not be breastfeeding
• prisoners or subjects who are involuntarily incarcerated
• subjects under guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bérengère OBSTOY

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2015/080/HP

Identifier Type: -

Identifier Source: org_study_id