Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-sm… (NCT02551211) | Clinical Trial Compass
TerminatedNot Applicable
Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer
Stopped: Difficulty in enrolling patients
France22 participantsStarted 2016-12-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of expression of the T regulator over total lymphocytes count ratio in the blood
Timeframe: Day 1
2
Level of expression of the T regulator over total lymphocytes count ratio into the tumor