Clinical trial · Interventional
Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR-BioMarkers (BM) Profiling)
- 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)
PIONeeR study is a prospective, multicenter study without administration of an investigational product. The promotion and funding will be done by the Assistance Publique Hôpitaux de Marseille (APHM), the coordination by AMU. There will be 3 principal investigational clinical centres in France: * Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques in APHM, Marseille, supervised by Prof. L. Greillier * Medical Oncology Department of Centre Léon Bérard, Lyon, supervised by Prof. M. Pérol * Unité d'Oncologie Thoracique, CHU Larrey /Oncopôle, Toulouse, supervised by Prof. J. Mazières. Some secondary centres, nearby the three principal mentioned above, will be associated to ensure recruitment of patients, in accordance to provisional planning. * The primary objective is to validate the existence and distribution of the hypothetical immune profile (within blood and tumoral tissue) explaining primary or adaptive resistance to standard PD-1 inhibitors monotherapy, in NSCLC patients. * The secondary objectives are to better characterize : * PK/PD relationships, * inter-patient PK variability, * If systemic exposure levels could be predictive of efficacy of PD-1 ICI, in NSCLC patients. * Some exploratory objectives are : * to assess a predictive value of a panel of endothelial biomarkers, in NSCLC patients. * to compare predictive immune \& endothelial biomarker profiles with those of sensitive tumors. * to better understand which profiles track significantly with progression following PD-1 ICI administration, in order to improve advanced NSCLC patients' stratification, for future clinical trials.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIOPSY | Procedure | — | UNRESOLVED |
| blood-sampled | Diagnostic Test | — | UNRESOLVED |
| feces samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NSCLC patients
- interventionNames
- Procedure: BIOPSY
- Diagnostic Test: blood-sampled
- Other: feces samples
Primary outcomes (1)
- measure
- Immuno-monitoring
- timeFrame
- 54 MONTHS
- description
- BLOOD SAMPLES to characterize B, T, NK, and dendritic cell subsets and monocyte populations as well as Innate Lymphoid Cells (ILC) with cytometry analysis
Secondary outcomes (6)
- measure
- Measure the number of somatic mutations
- timeFrame
- 54 MONTHS
- description
- BLOOD SAMPLES- extraction of nucleic acids from Plasma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Patients must be over 18 years * Patients must have histologically confirmed diagnosis of advanced (proven stade IV) or recurrent NSCLC, * Their ECOG Performance Status must be of 0 or 1 * EITHER patients must be previously untreated and eligible for an EMA approved first line PD-1 or PD-L1 inhibitor in combination with platinum-based chemotherapy, irrespective of their tumor histology * These EMA approved first line combinations must be reimbursed by French Health Insurance or at least, must have an Authorization for Temporary Use (ATU) in France * OR Patients must display disease progression after at least one line of platinum-based chemotherapy and eligible for a registered second or third line PD-1 or PD-L1 inhibitor in monotherapy (to date, Nivolumab, Pembrolizumab, Atezolizumab) * For patients registered for a 2nd or 3rd line, those with known actionable molecular alteration (EGFR activating mutation, ALK rearrangement, ROS1 rearrangement) should have received a specific inhibitor * Patients must have an available archived tissue from a standard tumor biopsy for PD-L1 assessment, done before PD-1 ICI initiation * Patients must have an available archived tissue from a standard tumor biopsy for PD-L1 assessment, done before PD-1 ICI initiation * Patients must have adequate organ functions * Patients must have provided a signed and dated, written informed consent prior to any study specific procedures, sampling and analyses Exclusion Criteria: * Patients previously untreated and eligible for a first line PD-1 or PD-L1 inhibitor in monotherapy * Combination of PD-1 or PD-L1 inhibitor with bevacizumab * Exclusive bone progression * Exclusive cerebral progression not amenable to surgical biopsy * Absence of a target lesion according to RECIST criteria 1.1 * Life expectancy of less than 3 months * Severe adverse events from PD-1 treatment * Abnormal coagulation contraindicating biopsy * History of hemorrhagic or thrombotic stroke, TIA or other CNS bleeds * Active uncontrolled or serious infection (viral, bacterial or fungal) * Active infection including VHB and VHC infections * Individuals deprived of liberty or placed under the authority of a tutor * Patient unable to understand, read and/or sign an informed consent * Any condition which in the Investigator's opinion would jeopardize compliance with the protocol of the study * Patients without Health insurance scheme or Universal Medical Coverage (CMU) or any equivalent scheme * Pregnant or breast-feeding women
References
Publications (0)
Data not yet available