Pilot Study of the Contribution of Fractional Exhaled Nit... | NCT05985330

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2023Actual

Primary Completion Date

Sep 2030Estimated

Completion Date

Sep 2030Estimated

First Submitted Date

Jul 24, 2023

First Submission Date that Met QC Criteria

Aug 8, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system to recognize and destroy cancer cells, and it has revolutionized the treatment of lung cancer.

However, the effectiveness of immunotherapy varies from patient to patient. At present, we have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a given individual.

Current scientific data identifies a number of molecules produced by the cancer cells and their environment which can be detected by various means (blood tests, breath analysis, etc.).

The aim of this study is to understand whether the amount of nitric oxide (NO) present in the breath is a more accurate predictor of response to immunotherapy.

Participation in this study involves breath testing (to measure FeNO (Fractional exhaled Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up visit after the 4th course of immunotherapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients with metastatic non-small-cell lung cancer	Other: Measurement of FeNO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of FeNO	Other	Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to immunotherapy by CT scan	Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.	after 4 courses of immunotherapy, an average of 9 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with metastatic NSCLC
Patient not previously treated
PD-L1 tumor expression > 50%, to be treated with immunotherapy alone after validation by a multidisciplinary consultation meeting.
Patients over 18 years of age
Patient having given his/her non-opposition
Patient who speaks and reads French

Exclusion Criteria:

Patients previously treated for NSCLC
Patient with oncogene addiction or a first-line targetable rearrangement
Patient not suitable for immunotherapy alone
Patient having received corticosteroid treatment in the 15 days prior to FeNO.
Patient on inhaled corticosteroid at time of inclusion.
Blood eosinophilia > 500 /mm3
Patient on 24-hour oxygen therapy
Contraindication to immunotherapy
Inability to perform FeNO measurement manoeuvres
Pregnant, parturient or breast-feeding women
Person under judicial protection (curatorship, guardianship)
Person subject to limited judicial protection
Adult unable to express their non-opposition
Patient refusing to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Marjolaine GEORGES	Contact	03.80.29.37.72		marjolaine.georges@chu-dijon.fr

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne	Recruiting	Dijon		21000	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases