Abstract 3666
Background
Non-small cell lung cancer (NSCLC) is one of the commonest disease worldwide and the leading cause of cancer-related death. Incidence increases with age and reaches a peak in senility, when patients’ (pts) comorbidities may limit the efficacy of treatments. At this time, no homogeneous indications are available for elderly NSCLC pts and the optimization of treatment, with the lowest side effects, is still an unmet need, also after the introduction of innovative drugs. The ribonucleotide reductase catalytic subunit M1(RRM1), the DNA-excision repair protein ERCC1 and the thymidylate synthetase (TS) are cancer molecular markers able to predict response to gemcitabine, platinum compounds and pemetrexd, respectively. Originally, aim of the EPIC study (active from July 2012) was to optimize survival of elderly NSCLC pts with the use of a genomic driven chemotherapy, comparing it to standard treatment. After the proven efficacy of first-line immunotherapy, on June 2018 the protocol was amended with the introduction of a new study arm, aiming to clarify the best strategy in this setting.
Trial design
EPIC is an Italian multicenter, randomized phase III trial, comparing Avelumab (A) vs genomic driven chemotherapy (B) and genomic driven chemotherapy vs standard chemotherapy according to investigator’s choice (C) in elderly untreated NSCLC pts, randomized in a 2:2:1 fashion manner. Age over 70 years, ECOG performance-status 0-1, stage IV non-oncogene addicted NSCLC and tissue availability for gene expression analysis, are key inclusion criteria. Before study entry, pharmacogenomic evaluations of RRM1, ERCC1 and TS is performed in the entire study population, but results are disclosed only to pts randomized in arm B to not influence subsequent treatments in the other arms. Primary endpoint of the EPIC study is overall survival (OS), while secondary endpoints include progression-free survival (PFS) and treatment response rate (by investigator’s assessment). Further objectives are the evaluation of feasibility of treatment selection based on pharmacogenomic parameters, and treatment-related toxicities in every study arm. End of enrollment is expected by the end of 2022.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Department of Oncology - University of Turin, Italy.
Funding
Italian Pharmacology Agency (AIFA).
Disclosure
E. Capelletto: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim. F. Grossi: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Roche; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis. P. Bidoli: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Boheringher; Advisory / Consultancy: BMS. O. Caffo: Honoraria (self): Pfizer ; Honoraria (institution): AstraZeneca. S. Novello: Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche ; Advisory / Consultancy: Takeda; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AbbVie; Advisory / Consultancy: Celgene. G. Scagliotti: Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer. All other authors have declared no conflicts of interest.
Resources from the same session
5152 - Comprehensive Geriatric Assessment (CGA) can categorize elderly glioblastoma (GBM) patients into three groups predicting survival: a monoinstitutional study
Presenter: Eleonora Bergo
Session: Poster Display session 1
Resources:
Abstract
4079 - Triggering anti-GBM immune response with EGFR-mediated photoimmunotherapy
Presenter: Gabriela Kramer-marek
Session: Poster Display session 1
Resources:
Abstract
4364 - Upregulation of sFRP3 circulating expression levels correlates survival outcomes in glioblastoma
Presenter: Gema Bruixola
Session: Poster Display session 1
Resources:
Abstract
2327 - Characterization and pre-clinical modeling of genetic aberrations in pediatric gliomas
Presenter: Itai Moshe
Session: Poster Display session 1
Resources:
Abstract
3154 - Preclinical Study of Novel Tetracyclic Small Molecule, CC12, for Brain Cancer
Presenter: Liyun Fann
Session: Poster Display session 1
Resources:
Abstract
5759 - CHLOROBRAIN phase IB trial: The addition of chloroquine, an autophagy inhibitor, to concurrent radiation and temozolomide for newly diagnosed glioblastoma
Presenter: Inge Compter
Session: Poster Display session 1
Resources:
Abstract
1382 - A Phase II Clinical Trial Evaluating the Efficacy and Safety of Apatinib Combined with dose-dense Temozolomide in Recurrent Glioblastoma
Presenter: Yong Wang
Session: Poster Display session 1
Resources:
Abstract
4407 - Phase 0 Trial of Ceritinib in Brain Metastases and Recurrent Glioblastoma
Presenter: Shwetal Mehta
Session: Poster Display session 1
Resources:
Abstract
1469 - Pembrolizumab (Pem) in recurrent high-grade glioma (HGG) patients with mismatch repair deficiency (MMRd): an observational study
Presenter: Mario Caccese
Session: Poster Display session 1
Resources:
Abstract
4217 - Outcome of high-grade gliomas (HGGs) treated into immunotherapeutic early-phase clinical trials (ieCTs): a single-center experience
Presenter: Matteo Simonelli
Session: Poster Display session 1
Resources:
Abstract