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
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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α-PD-1/PD-L1 plus chemoradiotherapy was tolerable in advanced NSCLC, HNSCC, and SCLC patients, with promising clinical outcomes, in phase 1/2 studies.
“Moreover, the results of some phase 1/2 studies (NCT02621398, NCT02434081, NCT02586207, NCT02383212, and NCT02402920) showed that α-PD-1/PD-L1 plus chemoradiotherapy was tolerable in advanced NSCLC, head and neck squamous cell carcinoma (HNSCC), and SCLC patients, with promising clinical outcomes [78–82].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [80]
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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
- Venue
- Lung Cancer
- Publisher
- Elsevier BV
- Published
- 2019-07
- Volume
- 133
- Pages
- 83-87
- ISSN
- 0169-5002 (ISSN-L)
- 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
- 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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