NCT07163507

Brief Summary

Lung cancer is the leading cause of cancer-related death worldwide, with nearly 2.48 million cases and 1.8 million deaths in 2022. Despite therapeutic progress, late diagnosis and high mortality make it a major public health issue. Immune checkpoint inhibitors (ICI) such as nivolumab, pembrolizumab, and atezolizumab have improved outcomes for some patients, but only a small proportion benefit, and side effects can be severe. Research is focusing on combining ICIs with chemotherapy, radiotherapy, or other immunotherapies, but reliable biomarkers to predict responders are still lacking. The tumor microenvironment, which promotes resistance, is a promising therapeutic target. The RICEPS study (2021-2023) found specific immune cells and cytokines linked to treatment response, and the ongoing RICEPS-2 trial aims to confirm these findings in a larger group to better understand immune dynamics in lung cancer under ICI therapy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress4%
Apr 2026Oct 2028

First Submitted

Initial submission to the registry

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

September 1, 2025

Last Update Submit

March 17, 2026

Conditions

Lung Cancer (NSCLC)Lung Cancer (Non-Small Cell)

Keywords

immunotherapysputum samplesblood samples

Outcome Measures

Primary Outcomes (2)

  • progression-free survival

    progression-free survival : The primary endpoint is the association of the change, between M0 and M3, in the relative frequency of cellular actors of innate and adaptive immune responses in the sputum and blood of patients treated with ICI, with their progression-free survival (PFS) at 12 months.

    12 months

  • Relative frequency of cellular players in innate and adaptive immune responses in the sputum of patients treated with ICI

    The secondary endpoint is the magnitude of the association between the relative frequency of cellular players of innate and adaptive immune responses in the sputum and blood of patients treated with ICI, with their progression-free survival (PFS) at 6 months.

    6 months

Study Arms (1)

study group

OTHER

This is the single arm of this study. Patients will provide at month 0, month 3 and month 6 1. 1 sputum sample after administration of isotonic saline nebulization and 2. 1 blood sample

Other: Blood sampleOther: sputum sample

Interventions

Blood sampleOTHER

Each patient will have a 5-10 ml blood sample taken at M0, M3, and M6.

study group
sputum sampleOTHER

Each patient will provide a sputum sample at M0, M3, and M6.

study group

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • Requiring initiation of treatment with anti-PD1 or anti-PDL1 ICI (nivolumab, pembrolizumab, atezolizumab, durvalumab, cemiplimab), with or without chemotherapy
  • Never having received ICI treatment
  • Affiliated with a social security system
  • Having signed a written, free, and informed consent form

You may not qualify if:

  • Pregnant or breastfeeding women
  • Individuals under guardianship, conservatorship, or judicial protection, or in a situation of deprivation of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marion FERREIRA, Dr

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion FERREIRA, Dr

CONTACT

247471640marion.ferreira@chu-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 9, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

FR(1)