1508TiP - The 1920-EORTC-BIORADON study: Molecular characterization of non-small cell lung cancer (NSCLC) and indoor radon exposure in Europe

Background

Lung cancer is the leading cause of cancer death worldwide. Radon is a radioactive gas tending to accumulate inside homes and it is considered one of the leading causes of lung cancer in non-smokers. The 2013/59 EURATOM directive regulates indoor radon in Europe, however regulating measures vary between countries. Radon emits alpha-ionizing radiation linked to a wide variety of cytotoxic/genotoxic effects; but the radon-associated molecular profile has never been described. Driver oncogenic alterations have been identified in non-small lung cancer (NSCLC), such as mutations (EGFR, ERBB2, BRAF, MET, etc.) or chromosomal fusions (ALK, ROS1, etc.), mainly in non-smokers, with no clear risk factor identified. Preliminary data suggest an association between radon and driver alterations in NSCLC. BIORADON’s primary objective is to study the correlation of molecular profiles of NSCLC in patients with indoor radon concentration with special focus on drivers.

Trial design

This is a prospective observational study of 975 patients with all-stages NSCLC. Patients with current/previous history of NSCLC (survivors up to 5 years) will be enrolled in 30 centers from 5 European countries (Spain, France, Portugal, Belgium, Italy). Participants must have been living in the current home for ≥2 years before the diagnosis and molecular profile must have been previously performed in routine care to classify patients in 3 cohorts (each cohort n=325): A: driver-mutation group; B: driver-fusion group and C: control group. Patients will receive two alpha-track detectors to measure radon at their home for ≥ 3 months and complete a questionnaire, including demographics, home characteristics, smoking/environmental/occupational exposure. After measurement, the detectors will be sent to a central laboratory for analysis. A blood sample is collected and archived FFPE specimen is optional for additional research. All clinical data are electronically collected. Secondary objectives are the correlation of clinical/pathological profiles with radon +/- other risk factors. The duration of the study is 3 years (since 04/22) and enrolment period is estimated to be 18 months. This study is part of the RADONORM Consortium.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

European Organisation for Research and Treatment of Cancer Research and Treatment of Cancer (EORTC).

Funding

EORTC; RADONORM.

Disclosure

L. Mezquita: Financial Interests, Personal, Advisory Board: Takeda, AstraZeneca, Roche; Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Takeda; Financial Interests, Personal, Research Grant, SEOM Beca Retorno 2019 : BI; Financial Interests, Personal, Research Grant, ESMO TR Research Fellowship 2019 : BMS; Financial Interests, Institutional, Research Grant, COVID research Grant: Amgen; Financial Interests, Institutional, Coordinating PI: Inivata, Stilla. M.E. Mauer: Financial Interests, Institutional, Funding, Funding to EORTC Headquarters to support conduct of this study: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD). I.G. Sullivan: Financial Interests, Personal, Advisory Board: Roche, Novartis, Boehringer Ingelheim, Takeda, Sanofi, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Takeda, Pfizer, Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel grant: Roche, Takeda, Lilly, AstraZeneca. L. Greillier: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, MSD, Novartis, Sanofi, Takeda, Roche; Financial Interests, Personal, Invited Speaker: Lilly, Pfizer; Financial Interests, Institutional, Local PI: AstraZeneca, AbbVie, BMS, MSD, Novartis, Takeda, Pfizer, PharmaMar; Financial Interests, Institutional, Coordinating PI: Sanofi; Financial Interests, Personal, Local PI: Roche. J. Rogado: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Merck, Ferrer, Persan Farma, Leo Pharma, Fresenius Kabi, BMS, MSD; Financial Interests, Personal, Advisory Board: Fresenius Kabi, MSD. M. Morfouace: Financial Interests, Institutional, Financially compensated role: Merck-group. A-M.C. Dingemans: Financial Interests, Institutional, Advisory Board: Roche, Sanofi, Amgen, Bayer, Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Takeda, Lilly, Jansen, Pfizer, AstraZeneca; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Local PI: Lilly, Amgen, Daiichi, JNJ, Mirati; Financial Interests, Institutional, Coordinating PI: Roche; Financial Interests, Institutional, Steering Committee Member: Roche; Non-Financial Interests, Other, Chair EORTC lung cancer group: EORTC; Non-Financial Interests, Member: IASCL, ASCO, AACR. B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, Eisai, Genzyme Corporation, Inivata, Ipsen, Turning Point Therapeutics. All other authors have declared no conflicts of interest.