Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+, Mozilla Firefox 20+, Internet Explorer 11, Opera 15–18, Apple Safari 7, SeaMonkey 2.15-2.23

  1. OncologyPRO
  2. Meeting resources
  3. ESMO 2018 Congress

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2355 - FOstering efficacy of anti-PD-1-treatment: nivolumab plus Radiotherapy in advanCEd non-small cell lung cancer - the FORCE trial

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Farastuk Bozorgmehr

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

F. Bozorgmehr1, A. Hommertgen2, F. Lasitschka3, J. Krisam4, J. Debus5, J.R. Fischer6, M. Bischof7, A. Atmaca8, S. Wetzel9, M. Faehling10, D. Bottke11, C. Grohe12, W. Engel-Riedel13, E. Ingenhoff14, D.F. Heigener15, N. Reinmuth16, C. Schumann17, M. Wermke18, M. Thomas1, S. Rieken19

Author affiliations

  • 1 Thoracic Oncology, Thoraxklinik at Heidelberg University Hospital; Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), 69126 - Heidelberg/DE
  • 2 Department Of Radiation oncology, Heidelberg University Hospital; Clinical Cooperation Unit Radiation oncology, German Cancer Research Center (dkfz), 69120 - Heidelberg/DE
  • 3 Institute Of Pathology, Heidelberg University Hospital; Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), 69120 - Heidelberg/DE
  • 4 Institute Of Medical Biometry And Informatics, University of Heidelberg, 69120 - Heidelberg/DE
  • 5 Department Of Radiation oncology, Heidelberg University Hospital, 69120 - Heidelberg/DE
  • 6 Department Of Thoracic Oncology, Lungenklinik Loewenstein, 74245 - Loewenstein/DE
  • 7 Department Of Radiation oncology, Klinikum am Gesundbrunnen, SLK-Kliniken Heilbronn GmbH, 74078 - Heilbronn/DE
  • 8 Department Of Hematology And Oncology, Krankenhaus Nordwest UCT-University Cancer Center, 60488 - Frankfurt am Main/DE
  • 9 Department Of Radiation oncology, Krankenhaus Nordwest, 60488 - Frankfurt am Main/DE
  • 10 Department Of Cardiology And Pneumology, Hospital Esslingen, 73730 - Esslingen/DE
  • 11 Department Of Radiation oncology, Hospital Esslingen, 73730 - Esslingen/DE
  • 12 Department Of Pneumology, ELK Berlin, 13125 - Berlin/DE
  • 13 Department Of Pneumology, City of Cologne Municipal Hospitals, Lung Hospital Cologne Merheim, 51109 - Köln/DE
  • 14 Department Of Radiation oncology, City of Cologne Municipal Hospitals, 51109 - Köln/DE
  • 15 Department Of Thoracic Oncology, Lungen Clinic Grosshansdorf, Airway Research Centre North (ARCN), Member of the German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 16 Department Of Thoracic Oncology, Asklepios Fachkliniken München-Gauting, 82131 - Gauting/DE
  • 17 Clinic For Pneumology, Thoracic Oncology, Sleep, And Respiratory Critical Care, Klinikum Kempten-Oberallgaeu gGmbH, 87439 - Kempten/DE
  • 18 Medizinische Klinik Und Poliklinik I, University Hospital Carl-Gustav-Carus, 01307 - Dresden/DE
  • 19 Department Of Radiation oncology, Heidelberg University Hospital; Heidelberg Institute of Radiation oncology (HIRO), Heidelberg, Germany, Heidelberg/DE
More

Abstract 2355

Background

Hypofractionated palliative radiotherapy for metastatic lung cancer patients is frequently used in order to ease pain, to increase bone stability, to treat local mass effects or to prolong progression-free survival at critical sites. Recently introduced, immunotherapy for patients with non-squamous non-small cell lung carcinoma (NSCLC) has significantly improved outcome in this cohort. Preclinical and early clinical data suggest that the combination of photon radiation with PD-1-targeting immunotherapies may promote a strong and durable immune response against tumor manifestations both within and beyond radiation targets.

Trial design

In this prospective, two-armed, non-randomized, open-label phase II trial, 130 patients with stage IV non-squamous non-small cell lung cancer in 2nd-line or 3rd-line treatment will be included. 65 patients with a clinical indication for palliative radiotherapy to non-cerebral non-pulmonary metastatic sites will receive nivolumab 240 mg followed by palliative radiotherapy with 5 x 4 Gy = 20 Gy photon radiation, which will be initiated within 72 hours after first nivolumab administration (Group A). 65 patients without an indication for radiotherapy will receive nivolumab (Group B). Nivolumab will be administered every two weeks in both groups and will be continued until progression or until limiting toxicities. The primary endpoint will be the objective response rate according to RECIST criteria 1.1. Secondary endpoints will be progression-free survival according to RECIST 1.1, overall survival, descriptive subgroup analyses according to PD-L1 expression, toxicity and quality of life. An extensive exploratory translational research program attached to this trial will focus on mechanisms of the immune-stimulating effect of radiotherapy and the identification of potential biomarkers predicting response to nivolumab. The FORCE trial will contribute prospective data to the observation that the combination of hypofractionated photon radiotherapy and medical immunotherapy is not only safe but will also promote antitumoral immune responses.

Clinical trial identification

NCT Nr: 03044626 Eudra-CT Nr: 2015-005741-31

Legal entity responsible for the study

AIO-Studien gGmbH.

Funding

Bristol Myers Squibb GmbH & Co. KGaA BMBF / NCT 3.0 BMBF / NCT 3.0.

Editorial Acknowledgement

Disclosure

F. Bozorgmehr: Research funding: BMS; Honoraria: MSD, Novartis. F. Lasitschka: Advisory board memberships: Roche Pharma, BMS; Corporate-sponsored research: Roche, MSD, BMS, Boehringer-Ingelheim, Morphosys, Dianova. J. Debus: Advisory board: Merck; Research support: Siemens, Accuray, Viewray. J.R. Fischer: Honoraria, Advisory boards, Presentations, Consulting: AstraZeneca, BMS, Boehringer Ingelheim, Celgene, MSD, Roche. M. Bischof: Advisory board: BMS. A. Atmaca: Honoraria for Advisory board participation and travel expenses: BMS. M. Faehling: Advisory boards: BMS, Roche, MSD, AstraZeneca. D.F. Heigener: Honoraria for presentations / Advisory board: Boehringer Ingelheim, BMS, Astra Zeneca, Roche, Lilly, Pfizer, Takeda, MSD. Travel expenses: Boehringer Ingelheim, BMS, Astra Zeneca, Roche, Lilly, Pfizer, Takeda, MSD. N. Reinmuth: Honoraria: Roche, Lilly, Novartis, MSD, BMS, Boehringer-Ingelheim, AstraZeneca, Pfizer, Takeda. C. Schumann: Advisory role and lectures: BMS, Astra, Roche, MSD. M. Wermke: Honoraria: BMS, Novartis, Roche, Bayer, Glenmark, AstraZeneca; Travel expenses: AstraZeneca, BMS, MSD, Novartis. M. Thomas: Presentations: Lilly; BMS; MSD; Roche; Pfizer; AstraZeneca; Advisory Boards: Lilly; BMS; MSD; Roche; Pfizer; AstraZeneca; Celgene; Mediolanum. S. Rieken: Honoraria and travel expenses: ELEKTA Inc., Accuray Inc., AstraZeneca GmbH, Brystol Myers Squibb, Lilly, Roche, DGP, DKG, DEGRO, Frauenselbsthilfe nach Krebs e.V., Berufsverband der Pharmaberater IITs and research funding: Brystal Myers Squibb, Accuray Inc., Merck KGaA Consulting or advisory role: Accuray Inc., AstraZeneca GmbH All other authors have declared no conflicts of interest.

Resources from the same session

5671 - The landscape of NTRK fusions in Chinese solid tumor patients

Presenter: Qi Ling

Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Resources:

Abstract

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings

  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.