Evidence map›Paper›PMID 36718142›Full record

ArticleJTO clinical and research reports2023

Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC.

Zoran Andric, Gabriella Gálffy, Manuel Cobo Dols, Barna Szima, Goran Stojanovic, Marina Petrovic, Enriqueta Felip, David Vicente Baz, Santiago Ponce Aix, Oscar Juan-Vidal and 11 more

Registry-linked trialAbstract read
In one paragraph

Article in JTO clinical and research reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03717155 (A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous NSCLC), which is not on this map. Not yet cited in PubMed.

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

NCT03717155 phase2completednot on this map

A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous NSCLC

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2018 to 2021Enrolled43ConditionsSquamous Non-Small Cell Lung CancerArmsAvelumab, Cetuximab, Gemcitabine, Cisplatin, Carboplatin
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Zoran AndricDepartment of Medical Oncology, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia.
Gabriella GálffyPulmonology Hospital Törökbálint, Törökbálint, Hungary.
Manuel Cobo DolsDepartment of Medical Oncology, Hospital Regional Universitario de Málaga, Institute of Biomedical Research of Málaga (IBIMA), Málaga, Spain.
Barna SzimaDepartment of Pulmonology, Markusovszky Hospital, Szombathely, Hungary.
Goran StojanovicInstitute of Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia.
Marina PetrovicClinic for Pulmonology, Clinical Center Kragujevac, Kragujevac, Serbia.
Enriqueta FelipVall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
David Vicente BazDepartment of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.
Santiago Ponce AixMedical Oncology Department, H120-CNIO Lung Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.
Oscar Juan-VidalDepartment of Medical Oncology, Hospital Universitari I Politècnic La Fe, Valencia, Spain.
Zsuzsanna SzalaiDepartment of Pulmonology, Aladar Petz University Teaching Hospital, Győr, Hungary.
Gyorgy LosonczyFaculty of Medicine, Semmelweis University, Budapest, Hungary.
Antonio Calles BlancoMedical Oncology Department, Hospital General Universitario Gregorio Marañon, Madrid, Spain.
Reyes BernabeDepartment of Medical Oncology, Hospital Universitario Virgen del Rocio, Seville, Spain.
Gema García LedoCentro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, Madrid, Spain.
Andrés Aguilar HernándezInstituto Oncológico Dr Rosell, Hospital Universitari Quiron Dexeus, Barcelona, Spain.
Klaus DueckerThe Healthcare Business of Merck KGaA, Darmstadt, Germany.
Dongli ZhouMerck Serono (Beijing) Pharmaceutical R&D Co., Ltd., Beijing, China.
Andreas SchroederThe Healthcare Business of Merck KGaA, Darmstadt, Germany.
Guelseren GuezelThe Healthcare Business of Merck KGaA, Darmstadt, Germany.
Fortunato CiardielloDivision of Medical Oncology, Department of Precision Medicine, The University of Campania Luigi Vanvitelli, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: We present the results of a phase 2a trial of first-line avelumab (anti-programmed death-ligand 1 antibody) plus cetuximab (anti-EGFR antibody) in patients with advanced squamous NSCLC. Methods: Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m Results: A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%-50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2-12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event. Conclusions: The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155).

Indexed as

AvelumabCetuximabEGFRNon–small cell lung cancerPD-L1

Identifiers

PMID36718142
PMCPMC9883276

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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.