Last updated on June 2019

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

Brief description of study

PIONeeR study is a prospective, multicenter study without administration of an investigational product.

The promotion and funding will be done by the Assistance Publique Hpitaux de Marseille (APHM), the coordination by AMU. There will be 3 principal investigational clinical centres in France:

  • Centre d'Essais Prcoces en Cancrologie de Marseille (CEPCM)-Unit de Phase I Oncologie lablise CLIP in APHM, Marseille, supervised by Prof. F. Barlesi
  • Medical Oncology Department of Centre Lon Brard, Lyon, supervised by Prof. M. Prol
  • Unit d'Oncologie Thoracique, CHU Larrey /Oncople, Toulouse, supervised by Prof. J. Mazires.

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.

Detailed Study Description

Visits will match with usual schedule of patient's appointments with their referent oncologist or for injections of ICIs, when blood sampling or biopsies will be done. Feces will be collected by patients themselves, at home (optional).

The same day of registration for a standard 2nd or 3rd line PD-(L) 1 ICIs monotherapy (to date, Nivolumab, Pembrolizumab, Atezolizumab), 450 advanced NSCLC patients will undergo a screening visit (Vs). If they are eligible, after signing an informed written consent, they will be blood-sampled specifically for the study:

  • 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),
  • and after 12 weeks of treatment (V4). Patients will also be re-biopsied (primitive tumor or metastasis) specifically for the study, at V2. Referent patients'oncologist will opt for the simplest technical approach with a minimal risk exposure for patients. Standard procedures will be implemented for subsequent patient's monitoring.

Patients will also provide remaining samples from pre-treatment surgical resections/biopsies (primitive tumor or metastasis).

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 after the 2nd (V2 - 6 weeks or V3- 8 weeks), depending on courses timelines.

Following the last study visit (V4), patients will enter to the follow up period (a maximum 2 years period). They will be followed by their usual referent oncologist, no additional visit is required. Subsequent response to the anti-PD (L) 1 treatment, anti-cancer therapy, survival will be collected via patient medical records and analysed for current study.

Clinical Study Identifier: NCT03493581

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Recruitment Status: Open

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