Evidence map›Paper›PMID 39349061›Full record

Trial reportJournal for immunotherapy of cancer2024

Single-arm trial of neoadjuvant ipilimumab plus nivolumab with chemoradiotherapy in patients with resectable and borderline resectable lung cancer: the INCREASE study.

Idris Bahce, Chris Dickhoff, Famke L Schneiders, Joris Veltman, David J Heineman, Sayed M S Hashemi, Anne Vrijmoet, Ilias Houda, Ezgi B Ulas, Joyce Bakker and 9 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04245514 (Immune-modulatory Radiotherapy to Enhance the Effects of Neoadjuvant PD-L1 Blockade After Neoadjuvant Chemotherapy in Patients With Resectable Stage III), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 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.

NCT04245514 phase2active not recruitingnot on this map

Immune-modulatory Radiotherapy to Enhance the Effects of Neoadjuvant PD-L1 Blockade After Neoadjuvant Chemotherapy in Patients With Resectable Stage III(N2) Non-small Cell Lung Cancer (NSCLC): A Multicenter Phase II Trial

TypeinterventionalSponsorSwiss Cancer InstituteRan2020 to 2031Enrolled90ConditionsNon-small Cell Lung Cancer, NSCLCArmsDurvalumab, Radiotherapy
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Guideline
  2. Pooled it
  3. Trial
  4. Management of borderline resectable NSCLC: a narrative review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  5. Review
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  7. Article
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  13. Observational
  14. Article
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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

19 authors.

Idris BahceDepartment of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, Noord-Holland, Netherlands i.bahce@amsterdamumc.nl.ORCID http://orcid.org/0000-0002-1111-608X
Chris DickhoffDepartment of Cardiothoracic Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Famke L SchneidersDepartment of Radiation Oncology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Joris VeltmanDepartment of Pulmonary Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
David J HeinemanDepartment of Cardiothoracic Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Sayed M S HashemiDepartment of Pulmonary Medicine, location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Anne VrijmoetDepartment of Pulmonary Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Noord-Holland, Netherlands.
Ilias HoudaDepartment of Pulmonary Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Ezgi B UlasDepartment of Pulmonary Medicine, Amsterdam UMC Locatie VUmc, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-1551-738X
Joyce BakkerDepartment of Medical Oncology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Peter van de VenDepartment of Epidemiology & Biostatistics, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Natalja BouwhuisDepartment of Clinical Pharmacology and Pharmacy, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Lilian J MeijboomDepartment of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Daniela E Oprea-LagerRadiology and Nuclear Medicine, Amsterdam UMC Locatie VUmc, Amsterdam, Netherlands.
Febe van MaldegemMolecular Cellular Biology and Immunology, Amsterdam UMC Location VUmc, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-2544-544X
Marieke F FransenDepartment of Pulmonary Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-3036-8618
Tanja D de GruijlDepartment of Medical Oncology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Teodora RadonicDepartment of Pathology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Noord-Holland, Netherlands.
Suresh SenanDepartment of Radiation Oncology, Amsterdam UMC Locatie VUmc, Amsterdam, Noord-Holland, Netherlands.ORCID http://orcid.org/0000-0003-3995-2204

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn non-small cell lung cancer (NSCLC), chemoradiotherapy (CRT) yields pathological complete response (pCR) rates of approximately 30%. We investigated using ipilimumab plus nivolumab (IPI-NIVO) with neoadjuvant CRT in resectable, and borderline resectable NSCLC.

methodsThis single-arm, phase-II trial enrolled operable T3-4N0-2 patients with NSCLC without oncogenic drivers. Primary study endpoints were safety, major pathological response (MPR) and pCR. Treatment encompassed platinum-doublet concurrent CRT, IPI 1 mg/kg intravenous and NIVO 360 mg intravenous on day-1, followed by chemotherapy plus NIVO 360 mg 3 weeks later. Thoracic radiotherapy was 50 or 60 Gy, in once-daily doses of 2 Gy. Resections were 6 weeks post-radiotherapy.

resultsIn a total of 30 patients in the intention-to-treat (ITT) population, grades 3-4 treatment-related adverse events (TRAEs) occurred in 70%, one TRAE grade 5 late-onset pneumonitis on day 96 post-surgery (1/30, 3.3%) occurred, and one non-TRAE COVID-19 death (1/30, 3.3%). pCR and MPR were achieved in 50% (15/30) and 63% (19/30) of the ITT; and in 58% (15/26) and 73% (19/26) of the 26 patients who underwent surgery, respectively. Postoperative melanoma was seen in one non-pCR patient. The R0 rate was 100% (26/26), and no patient failed surgery due to TRAEs. In peripheral blood, proliferative CD8

conclusionsNeoadjuvant IPI-NIVO-CRT in T3-4N0-2 NSCLC showed acceptable safety with pCR and MPR in 58% and 73% of operated patients, respectively. No patient failed surgery due to TRAEs. TRIAL REGISTRATION NUMBER: NCT04245514.

Indexed as

IpilimumabLung NeoplasmsNeoadjuvant TherapyNivolumabAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungChemoradiotherapyFemaleHumansMaleMiddle AgedIpilimumabNivolumabChemotherapyIpilimumabNivolumabRadiotherapy

Identifiers

PMID39349061
PMCPMC11448277

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.