Clinical trial · Interventional
Immune Response to Immunotherapy in Lung Cancer: Study of Sputum and Blood Samples
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Non-Small Cell) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Other | — | UNRESOLVED |
| sputum sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- study group
- description
- 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
- interventionNames
- Other: Blood sample
- Other: sputum sample
Primary outcomes (2)
- measure
- progression-free survival
- timeFrame
- 12 months
- description
- 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.
- measure
- Relative frequency of cellular players in innate and adaptive immune responses in the sputum of patients treated with ICI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: . 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 Exclusion Criteria: * Pregnant or breastfeeding women * Individuals under guardianship, conservatorship, or judicial protection, or in a situation of deprivation of liberty
References
Publications (0)
Data not yet available