NCT02551211

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 14, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

September 14, 2015

Last Update Submit

April 28, 2026

Conditions

Resectable Non-small Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Level of expression of the T regulator over total lymphocytes count ratio in the blood

    Day 1

  • Level of expression of the T regulator over total lymphocytes count ratio into the tumor

    Day 1

Secondary Outcomes (2)

  • Number of cell population counts as blood markers for the corresponding population in the tumor

    Day 1

  • Number of patient alive 2 years after resection

    2 years

Study Arms (1)

Patients with resectable non-small cell lung cancer

EXPERIMENTAL
Procedure: blood drawnProcedure: surgical resection of cancer

Interventions

blood drawnPROCEDURE

blood drawn

Patients with resectable non-small cell lung cancer
surgical resection of cancerPROCEDURE
Patients with resectable non-small cell lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Study Officials

  • Bérengère OBSTOY

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 16, 2015

Study Start

December 14, 2016

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

FR(1)