Resectable Non-small Lung CancerLYMPHOLUNGNCT02551211
Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer
A study testing blood drawn and surgical resection of cancer in people with Resectable Non-small Lung Cancer, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Non-small Lung Cancer
- What is being tested?
- blood drawn and surgical resection of cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2016to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- blood drawn, surgical resection of cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawnProcedure or surgery
blood drawn
surgical resection of cancerProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with resectable non-small cell lung cancer | Experimental | Not described Receives: Procedure: blood drawn; Procedure: surgical resection of cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of expression of the T regulator over total lymphocytes count ratio in the blood
Measured: Day 1
Level of expression of the T regulator over total lymphocytes count ratio into the tumor
Measured: Day 1
Secondary outcomes (2)
Number of cell population counts as blood markers for the corresponding population in the tumor
Measured: Day 1
Number of patient alive 2 years after resection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start14 Dec 2016
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Why it stopped: Difficulty in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Non-small Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bérengère OBSTOY, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551211
- Sponsor's protocol ID
- 2015/080/HP
- Acronym
- LYMPHOLUNG
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2015
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02551211
- Acronym / sponsor ID
- LYMPHOLUNG / 2015/080/HP
- Conditions
- Resectable Non-small Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling patients
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with resectable non-small cell lung cancer | Experimental | Procedure: blood drawn, Procedure: surgical resection of cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawnblood drawn | Procedure or surgery | Patients with resectable non-small cell lung cancer |
| surgical resection of cancer | Procedure or surgery | Patients with resectable non-small cell lung cancer |
Primary outcome
Level of expression of the T regulator over total lymphocytes count ratio in the blood
Time frame: Day 1
Level of expression of the T regulator over total lymphocytes count ratio into the tumor
Time frame: Day 1
2 secondary outcomes
Number of cell population counts as blood markers for the corresponding population in the tumor
Time frame: Day 1
Number of patient alive 2 years after resection
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bérengère OBSTOY principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood drawn and surgical resection of cancer in people with Resectable Non-small Lung Cancer, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of expression of the T regulator over total lymphocytes count ratio in the blood (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.