Evidence map›Paper›PMID 37524953›Full record

Trial reportNature medicine2023

Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial.

Manish A Shah, Kohei Shitara, Jaffer A Ajani, Yung-Jue Bang, Peter Enzinger, David Ilson, Florian Lordick, Eric Van Cutsem, Javier Gallego Plazas, Jing Huang and 11 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 458 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
458citing papers in PubMed, 4 pooled it
125.6field-weighted citation impact, top 1% of its field
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.

NCT03653507 phase3active not recruitingnot on this map

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2018 to 2026Enrolled507ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaArmszolbetuximab, oxaliplatin, capecitabine, placebo
NCT06767449 recruitingnot on this mapstarted 2024, after this paper: background citation

Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Zolbetuximab Plus Chemotherapy in Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer

Typeobservational_patient_registrySponsorYonsei UniversityRan2024 to 2026Enrolled80ConditionsAdvanced Gastric Cancer
NCT07427992 recruitingnot on this mapstarted 2025, after this paper: background citation

Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma

TypeobservationalSponsorEuropean Institute of OncologyRan2025 to 2027Enrolled70ConditionsGastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
3 · Its place in the literature

Who cites it

458 citing papers in PubMed, 4 syntheses or guidelines pooled it, 486 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Japanese gastric cancer treatment guidelines 2025 (7th edition).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. A phase II trial of ramucirumab and docetaxel as second-line treatment for patients with advanced gastric cancer (HGCSG 1903).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Trial
  8. Trial
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  11. Trial
  12. Review
  13. Article
  14. Article
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  16. Article
  17. Importance of Inclusion of Representative Populations in Pivotal Clinical Trials: Zolbetuximab as an Example.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  18. Review
  19. Review
  20. Article

398 more citing papers are in PubMed but not listed here.

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 at 17 institutions in 10 countries.

Manish A ShahWeill Cornell Medical College, New York City, NY, USA.ORCID http://orcid.org/0000-0002-6913-9655
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa City, Japan.ORCID http://orcid.org/0000-0001-5196-3630
Jaffer A AjaniThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-9946-0629
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-6000-4597
Peter EnzingerCenter for Esophageal and Gastric Cancer, Dana-Farber Cancer Institute, Boston, MA, USA.
David IlsonMemorial Sloan Kettering Cancer Center, New York City, NY, USA.
Florian LordickDepartment of Medicine and University Cancer Center Leipzig, University of Leipzig Medical Center, Leipzig, Germany.
Eric Van CutsemDigestive Oncology, University Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, Belgium.
Javier Gallego PlazasDepartment of Medical Oncology, Hospital General Universitario de Elche, Elche, Spain.
Jing HuangDepartment of Medical Oncology, National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.ORCID http://orcid.org/0000-0002-2167-8385
Lin ShenDepartment of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China.
Sang Cheul OhDepartment of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
Patrapim SunpaweravongDepartment of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.
Hwoei Fen Soo HooDepartment of Oncology and Radiotherapy, Penang Hospital, Penang, Malaysia.
Haci Mehmet TurkDepartment of Medical Oncology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.ORCID http://orcid.org/0000-0003-2206-8148
Mok OhAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Jung Wook ParkAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Diarmuid MoranAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Pranob BhattacharyaAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Ahsan ArozullahAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Rui-Hua XuState Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China. xurh@sysucc.org.cn.ORCID http://orcid.org/0000-0001-9771-8534
Astellas Pharma (United States) · USBezmiâlem Vakıf Üniversitesi · TRChinese Academy of Medical Sciences & Peking Union Medical College · CNCornell University · USDana-Farber Cancer Institute · USHospital General Universitario de Elche · ESKorea University Medical Center · KRKU Leuven · BELeipzig University · DEMemorial Sloan Kettering Cancer Center · USNational Cancer Center Hospital East · JPPeking University · CNPenang Adventist Hospital · MYPrince of Songkla University · THSeoul National University · KRSun Yat-sen University · CNThe University of Texas MD Anderson Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

There is an urgent need for first-line treatment options for patients with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. Claudin-18 isoform 2 (CLDN18.2) is expressed in normal gastric cells and maintained in malignant G/GEJ adenocarcinoma cells. GLOW (closed enrollment), a global, double-blind, phase 3 study, examined zolbetuximab, a monoclonal antibody that targets CLDN18.2, plus capecitabine and oxaliplatin (CAPOX) as first-line treatment for CLDN18.2-positive, HER2-negative, locally advanced unresectable or mG/GEJ adenocarcinoma. Patients (n = 507) were randomized 1:1 (block sizes of two) to zolbetuximab plus CAPOX or placebo plus CAPOX. GLOW met the primary endpoint of progression-free survival (median, 8.21 months versus 6.80 months with zolbetuximab versus placebo; hazard ratio (HR) = 0.687; 95% confidence interval (CI), 0.544-0.866; P = 0.0007) and key secondary endpoint of overall survival (median, 14.39 months versus 12.16 months; HR = 0.771; 95% CI, 0.615-0.965; P = 0.0118). Grade ≥3 treatment-emergent adverse events were similar with zolbetuximab (72.8%) and placebo (69.9%). Zolbetuximab plus CAPOX represents a potential new first-line therapy for patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or mG/GEJ adenocarcinoma. ClinicalTrials.gov identifier: NCT03653507 .

Indexed as

AdenocarcinomaStomach NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineClaudinsEsophageal NeoplasmsEsophagogastric JunctionHumansOxaliplatinAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCapecitabineClaudinsCLDN18 protein, humanOxaliplatinzolbetuximab

Identifiers

PMID37524953
PMCPMC10427418
OpenAlexW4385429828

What OpenQuestion holds

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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.