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Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-radiotherapy regimen in stage III non-small cell lung cancer—The ETOP NICOLAS trial

Peters, S., Felip, E., Dafni, U., Belka, C., Guckenberger, M., Irigoyen, A., Nadal, E., Becker, A., Vees, H., Pless, M., Martinez-Marti, A., Tufman, A., Lambrecht, M., Andratschke, N., Piguet, A.C., Kassapian, M., Roschitzki-Voser, H., Rabaglio-Poretti, M., Stahel, R.A., Vansteenkiste, J., De Ruysscher, D.·2019·Lung Cancer

DOI 10.1016/j.lungcan.2019.05.001

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Abstract

Objectives Chemo-radiotherapy (CRT) and concurrent PD-1 inhibition has shown promising results in pre-clinical models. So far, the feasibility of delivering concurrent CRT and PD-1/PD-L1 inhibition has never been assessed in a clinical trial.Material and methods NICOLAS is a phase-II trial evaluating the safety and efficacy of nivolumab combined with CRT in stage III NSCLC. Patients received 3 cycles of platinum-based chemotherapy and concurrent RT (66 Gy/33fractions). Nivolumab started concurrently with RT. The primary endpoint was 6-month post-RT rate of grade-≥3-pneumonitis. A formal interim safety analysis (IA) was scheduled when the first 21 patients reached 3 months follow-up post-RT. An early positive safety conclusion would be reached at IA if there were no grade ≥3-pneumonitis in those patients. Efficacy evaluation was planned provided the safety conclusion was reached.Results and conclusion As of 13 December 2018, 82 patients were recruited with median follow-up of 13.4 months. The most frequent adverse events (AEs) were anaemia, fatigue and pneumonitis. No unexpected AEs or increased toxicities were observed. For the first 21 patients, no grade-≥3-pneumonitis was observed by the end of the 3-month post-RT follow-up period. The early safety IA provides evidence that the addition of nivolumab to concurrent CRT is safe and tolerable regarding the 6-month rate of pneumonitis grade ≥3 at the one-sided significance level of 5%. Following that, the 1-year progression-free survival will be evaluated in an expanded patient cohort. NICOLAS trial creates the opportunity for assessing the activity of the combination of checkpoint with concurrent CRT in larger prospective trials for locally advanced NSCLC.

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Authors: Peters, S., Felip, E., Dafni, U., Belka, C., Guckenberger, M., Irigoyen, A., Nadal, E., Becker, A., Vees, H., Pless, M., Martinez-Marti, A., Tufman, A., Lambrecht, M., Andratschke, N., Piguet, A. C., Kassapian, M., Roschitzki-Voser, H., Rabaglio-Poretti, M., Stahel, R. A., Vansteenkiste, J., & De Ruysscher, D.
Affiliations: Centre Hospitalier Universitaire Vaudois (CH)
Vall d'Hebron Hospital Universitari (ES)
National and Kapodistrian University of Athens (GR)
LMU Klinikum (DE)
Hospital Virgen de la Salud (ES)
Institut d'Investigació Biomédica de Bellvitge (ES)
Klinik Hirslanden (CH)
Kantonsspital Winterthur (CH)
German Center for Lung Research (DE)
Universitair Ziekenhuis Leuven (BE)
University of Zurich (CH)
European Thoracic Oncology Platform (CZ)
Frontier Science Foundation-Hellas (GR)
University Hospital Zurich (CH)
ORCID: Peters, S.
Felip, E.
Dafni, U.
Belka, C.
Guckenberger, M.
Nadal, E.
Pless, M.
Tufman, A.
Lambrecht, M.
Andratschke, N.
Roschitzki-Voser, H.
Stahel, R.A.
Vansteenkiste, J.
Venue: Lung Cancer
Publisher: Elsevier BV
Published: 2019-07
Volume: 133
Pages: 83-87
ISSN: 0169-5002 (ISSN-L)
DOI: 10.1016/j.lungcan.2019.05.001
OpenAlex: W2943437728
Cited by: 162
References: 12
Citations by year: 2026: 8 · 2025: 22 · 2024: 19 · 2023: 18 · 2022: 24 · 2021: 33 · 2020: 35 · 2019: 3
FWCI: 17.44
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Lung Cancer (publishedVersion)
PubMed (publishedVersion)
Bern Open Repository and Information System (University of Bern) (submittedVersion)
Research Publications (Maastricht University) (submittedVersion)
IRIS (submittedVersion)
Lirias (KU Leuven) (submittedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
SERVAL (Université de Lausanne) (submittedVersion)
Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: ETOP
Bristol-Myers Squibb
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Keywords: nivolumab, concurrent chemoradiotherapy, non-small cell lung cancer, stage III NSCLC, anti-PD-1 therapy, PD-L1 blockade, pneumonitis, treatment safety, platinum-based chemotherapy, immune checkpoint inhibitors, locally advanced non-small cell lung cancer
MeSH terms: Nivolumab, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Cohort Studies, Survival Analysis, Treatment Outcome, Platinum Compounds, Chemoradiotherapy, B7-H1 Antigen, Programmed Cell Death 1 Receptor

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Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-radiotherapy regimen in stage III non-small cell lung cancer—The ETOP NICOLAS trial

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