Immune Response to Immunotherapy in Lung Cancer: Study of Sputum and Blood Samples
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant or breastfeeding women
Individuals under guardianship, conservatorship, or judicial protection, or in a situation of deprivation of liberty
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample
Other interventionEach patient will have a 5-10 ml blood sample taken at M0, M3, and M6.
sputum sample
Other interventionEach patient will provide a sputum sample at M0, M3, and M6.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: study groupOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: