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Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR-BioMarkers (BM) Profiling)

NCT03493581 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2023-06-26

No results posted yet for this study

Summary

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

  • Non-small Cell Lung Cancer Patients

Interventions

PROCEDURE

BIOPSY

re-biopsy (primitive tumor or metastasis) specifically for the study, at V2(6 weeks)

DIAGNOSTIC_TEST

blood-sampled

* after 3 or 4 weeks (V1-1st assessment of PK/PD, after the 2d course), * after 6 weeks (V2), * after 8 or 9 weeks (V3-2nd assessment of PK/PD, after the last course), * \- after 12 weeks of treatment (V4- samples for 3rd assessment of PK/PD and other analyses ). * after 18 weeks (V5- samples for 4th assessment of PK/PD and other analyses,), * after 24 weeks of treatment (V6-5th assessment of PK/PD and other analyses).

OTHER

feces samples

If they are amenable to collect feces samples at home, an auto collection kit will be supplied to them, before the first injection (Vs) and when they come for the 2nd course (i.e after 3 or 4 weeks post initiation) in order to self-collect feces within the week beforeV2 - 6 weeks post initiation).

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2024-03-08
Completion
2024-08-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493581 on ClinicalTrials.gov