Evidence map›Paper›PMID 40702361›Full record

Trial reportClinical & experimental metastasis2025

Reconsidering palliative radiotherapy in addition to PD-1 blockade for non-small cell lung cancer: results from the FORCE phase II trial (AIO/YMO-TRK-0415).

Farastuk Bozorgmehr, Inn Chung, Jürgen R Fischer, Marc Bischof, Akin Atmaca, Sophie Wetzel, Martin Faehling, Dirk Bottke, Martin Wermke, Esther G C Troost and 29 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical & experimental metastasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03044626 (Fostering Efficacy of Anti - PD-1 - Treatment), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03044626 phase2completednot on this map

Fostering Efficacy of Anti - PD-1 - Treatment: Nivolumab Plus Radiotherapy in Advanced NSCLC

TypeinterventionalSponsorAIO-Studien-gGmbHRan2017 to 2020Enrolled101ConditionsCarcinoma,Non-Small-Cell Lung, Metastatic Lung Cancer, Nonsmall Cell Lung Cancer, Lung Adenocarcinoma MetastaticArmsRadiotherapy, Nivolumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors.

Farastuk BozorgmehrDepartment of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany. Farastuk.Bozorgmehr@med.uni-heidelberg.de.
Inn ChungDepartment of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany.
Jürgen R FischerDepartment of Thoracic Oncology, Lungenklinik Loewenstein, Loewenstein, Germany.
Marc BischofDepartment of Radiation Oncology, Klinikum Am Gesundbrunnen, SLK-Kliniken Heilbronn GmbH, Heilbronn, Germany.
Akin AtmacaDepartment of Hematology and Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany.
Sophie WetzelDepartment of Radiation Oncology, Krankenhaus Nordwest, Frankfurt, Germany.
Martin FaehlingDepartment of Cardiology and Pneumology, Klinikum Esslingen, Esslingen, Germany.
Dirk BottkeDepartment of Radiation Oncology, MVZ Klinikum Esslingen, Esslingen, Germany.
Martin WermkeMedizinische Fakultät Carl-Gustav-Carus der Technischen Universität, Medizinische Klinik Und Poliklinik I, University Hospital Carl-Gustav-Carus, National Center for Tumor Diseases (NCT)-Partner Site Dresden, Medizinische Fakultät der Technischen Universität, Universitätskrebscentrum, Early Clinical Trial Unit, German Cancer Consortium (DKTK), Partner Site Dresden, Dresden, Germany.
Esther G C TroostDepartment of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, Dresden, Germany.
Cornelia Kropf-SanchenDepartment of Pneumology, University Hospital Ulm, Ulm, Germany.
Thomas WiegelDepartment of Radiotherapy and Radiation Oncology, University Hospital Ulm, Ulm, Germany.
Bernd SchmidtDepartment of Internal Medicine, Pneumology and Sleep Medicine, DRK Kliniken Berlin Mitte, Berlin, Germany.
Andrej StupavskyDepartment of Radiation Oncology, DRK Kliniken Berlin Westend, Berlin, Germany.
Walburga Engel-RiedelDepartment of Pneumology, City of Cologne Municipal Hospitals, Lung Hospital Cologne Merheim, Cologne, Germany.
Michaela Hammer-HellmigDepartment of Radiation Oncology, City of Cologne Municipal Hospitals, Cologne, Germany.
Niels ReinmuthDepartment of Thoracic Oncology, Asklepios Fachkliniken München-Gauting, Member of the German Center for Lung Research (DZL), Gauting, Germany.
Farkhad ManapovDepartment of Radiation Oncology, University Hospital Munich (LMU), Munich, Germany.
Christian GroheDepartment of Pneumology, Evangelische Lungenklinik Berlin, Berlin, Germany.
Robert KrempienDepartment of Radiation Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany.
Christian SchumannClinic for Pneumology, Thoracic Oncology, Sleep, and Respiratory Critical Care, Allgäu Clinics, Kempten and Immenstadt, Immenstadt, Germany.
Florian SterzingDepartment of Radiation Oncology, Klinikum Kempten, Kempten, Germany.
Martin ReckDepartment of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Centre North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.
Florian WürschmidtRadiologische Allianz, Hamburg, Germany.
Jochen FleckensteinDepartment of Radiotherapy and Radiation Oncology, Saarland University Medical Center, Homburg, Germany.
Alev PetroffDepartment of Radiotherapy and Radiation Oncology, Saarland University Medical Center, Homburg, Germany.
Sven HenschkeInternal Medicine V, Saarland University Medical Center, Homburg, Germany.
Rouven BehnischInstitute of Medical Biometry, Heidelberg University, Heidelberg, Germany.
Jelena CvetkovicDepartment of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany.
Lena BrücknerDepartment of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany.
Constantin SchwabTranslational Lung Research Center Heidelberg TLRC-H, Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
Albrecht StenzingerTranslational Lung Research Center Heidelberg TLRC-H, Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
Thorsten GötzeInstitut Für Klinische Krebsforschung IKF GmbH Am Krankenhaus Nordwest, Frankfurt, Germany.
Christina KoppInstitut Für Klinische Krebsforschung IKF GmbH Am Krankenhaus Nordwest, Frankfurt, Germany.
Helge SchröderAIO-Studien gGmbH, Berlin, Germany.
Jürgen DebusDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Petros ChristopoulosDepartment of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany.
Michael ThomasDepartment of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany.
Stefan RiekenDepartment of Radiotherapy and Radiation Oncology, University Medical Center Goettingen, Goettingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction of immune checkpoint inhibitors (ICI) has improved overall survival (OS) for advanced non-small cell lung cancer (NSCLC). However, responses differ greatly amongst patients. Additional radiotherapy (RT) may promote tumor-specific immunity and synergize with ICI to improve tumor control. The multicenter phase II FORCE trial evaluated safety and efficacy of nivolumab with additional palliative radiotherapy (5 × 4 Gy) as clinically indicated in pre-treated metastatic non-squamous NSCLC (group A, n = 41), including pretreated patients without an indication for radiotherapy in a parallel cohort as real-world controls (group B, n = 60). With an objective response rate (ORR) of 8.3% in group A (n = 41), the primary endpoint was not met (p = 0.991). ORR in group B (n = 60) was 23.8%. Patient characteristics indicated a significantly poorer baseline clinical condition for group A compared to B, including worse Eastern Cooperative Oncology Group (ECOG) performance status (PS, p = 0.020) and more metastatic sites (p = 0.009). Consequently, group A had shorter progression-free survival (median PFS, 1.9 versus 3.7 months, hazard ratio [HR] 1.69 [95% CI (1.10, 2.58)]) and OS (median 6.0 versus 12.6 months, HR 1.75 [95% CI (1.07, 2.84)]). In multivariable analyses for the intention-to-treat (ITT) population, ORR, PFS and OS were inversely associated with the patients' ECOG PS (ORR odds ratio [OR] 0.126, p = 0.004) and correlated positively with tumor PD-L1 expression (ORR OR 12.8, p = 0.022), but not with radiotherapy administration (p = 0.169-0.854). Adverse events were distributed equally in both groups. Addition of palliative radiotherapy to nivolumab was safe and feasible, but not associated with improved efficacy. Patients with an indication for palliative radiotherapy have an inherently worse prognosis which cannot be overcome by radiation-induced immunostimulation. Clinical features and PD-L1 expression influence clinical outcomes more than radiotherapy administration and should be considered when evaluating the effectiveness of immuno-/radiotherapy combinations.ClinicalTrials.gov identifier: NCT03044626.

Indexed as

Carcinoma, Non-Small-Cell LungImmune Checkpoint InhibitorsLung NeoplasmsNivolumabPalliative CareAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgrammed Cell Death 1 ReceptorImmune Checkpoint InhibitorsNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorImmunotherapyNivolumabNon-small cell lung cancerPalliative radiotherapyRadioimmunotherapy

Identifiers

PMID40702361
PMCPMC12287132

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Registered trials

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