Evidence map›Paper›PMID 39448966›Full record

ArticleBMC cancer2024

Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC.

Armando Santoro, Garrido Pilar, Daniel S W Tan, Jon Zugazagoitia, Frances A Shepherd, Alessandra Bearz, Fabrice Barlesi, Tae Min Kim, Tobias R Overbeck, Enriqueta Felip and 4 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase I
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03064854 (Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03064854 phase1terminatednot on this map

Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2021Enrolled111ConditionsNon-small Cell Lung CancerArmsPDR001, Cisplatin, Gemcitabine, Pemetrexed, Carboplatin
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Armando SantoroDepartment of Biomedical Sciences, Humanitas University, Milan, Italy. armando.santoro@cancercenter.humanitas.it.
Garrido PilarDepartment of Medical Oncology, Hospital Ramón Y Cajal, Madrid, Spain.
Daniel S W TanDepartment of Medical Oncology, National Cancer Center Singapore, Singapore, Singapore.
Jon ZugazagoitiaDepartment of Medical Oncology, University Hospital 12 de Octubre, Madrid, Spain.
Frances A ShepherdDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Alessandra BearzDepartment of Medical Oncology, Centro di Riferimento Oncologico - CRO, Aviano, Italy.
Fabrice BarlesiDepartment of Multidisciplinary Oncology and Therapeutic Innovations, Aix Marseille University, CNRS, INSERM, CRCM, APHM, CEPCM, CLIP, Marseille, France.
Tae Min KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Tobias R OverbeckDepartment of Hematology and Medical Oncology, University Medical Center Göttingen, Göttingen, Germany.
Enriqueta FelipDepartment of Medical Oncology Service, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Can CaiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Simantini EddyNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Tracey McCullochNovartis Pharma AG, Basel, Switzerland.
Eric S SchaeferDepartment of Medical Oncology, Highlands Oncology Group, Fayetteville, AZ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite promising outcomes of treatment with anti-programmed cell death (PD)-1/PD-ligand (L)1 agents in combination with platinum-doublet chemotherapy (PDC) in the first-line setting, a significant unmet medical need remains in patients with PD-L1-unselected non-small cell lung cancer (NSCLC).

methodsThis multicenter, open-label, phase 1b study comprising dose-confirmation and dose-expansion parts investigated the combination of spartalizumab and various PDC regimens, with or without canakinumab, in treatment-naïve patients with PD-L1-unselected, metastatic NSCLC. The primary objectives were to determine maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of spartalizumab, with or without canakinumab, in combination with PDC in the dose-confirmation part and antitumor activity of spartalizumab in the dose-expansion part.

resultsThe MTD/RDE of spartalizumab was 300 mg every 3 weeks (Q3W) when administered with either gemcitabine (1250 mg/m

conclusionsThe combination of spartalizumab and PDC, with or without canakinumab, was well tolerated across treatment groups. The antitumor activity across treatment groups was comparable with that of pembrolizumab and pemetrexed combination. Canakinumab did not appear to improve the antitumor activity when combined with spartalizumab, pemetrexed and cisplatin.

trial registrationThe trial was registered in Clinicaltrials.gov with identifier no. NCT03064854. Date of Registration: 06 February 2017.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarcinoma, Non-Small-Cell LungLung NeoplasmsAdultAgedCarboplatinCisplatinDeoxycytidineFemaleGemcitabineHumansMaleMaximum Tolerated DoseMiddle AgedAntibodies, Monoclonal, HumanizedB7-H1 AntigencanakinumabCarboplatinCD274 protein, humanCisplatinDeoxycytidineGemcitabinespartalizumabCanakinumabNSCLCPD-L1Platinum-doublet chemotherapySpartalizumab

Identifiers

PMID39448966
PMCPMC11515544

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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.