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Observational Study
. 2025 Feb;14(2):e240127.
doi: 10.57264/cer-2024-0127. Epub 2025 Jan 21.

MOMENT registry: Patients with advanced non-small-cell lung cancer harboring MET exon 14 skipping treated with systemic therapy

Michael Thomas  1 , Petros Christopoulos  1 , Wade T Iams  2 , Julien Mazières  3 , Alexis B Cortot  4 , Nir Peled  5 , Gabriele Minuti  6 , Egbert F Smit  7 , Francois Audhuy  8 , Karin Berghoff  9 , S Peter Eggleton  10 , Frank Fries  11 , Maike Hildenbrand  12 , Peter Liu  13 , Seyed Hamidreza Mahmoudpour  14 , Christoph Menzel  12 , Dina Oksen  14
Affiliations
Observational Study

MOMENT registry: Patients with advanced non-small-cell lung cancer harboring MET exon 14 skipping treated with systemic therapy

Michael Thomas et al. J Comp Eff Res. 2025 Feb.

Abstract

Aim: MET exon 14 (METex14) skipping occurs in 3-4% of non-small-cell lung cancer (NSCLC) cases. Low frequency of this alteration necessitated open-label, single-arm trials to investigate MET inhibitors. Since broad MET biomarker testing was only recently introduced in many countries, there is a lack of historical real-world data from patients with METex14 skipping NSCLC receiving conventional therapies. Given the rarity of this population and limitations of existing real-world data sources, the MOMENT registry aims to prospectively collect uniform, comprehensive, high-quality data from patients with METex14 skipping advanced NSCLC treated in routine clinical practice, which can support clinical and regulatory decision making. Patients & methods: MOMENT is a multinational, non-interventional disease registry collecting data on patients with METex14 skipping advanced NSCLC receiving any systemic anticancer therapy. Newly diagnosed patients and those already receiving treatment are eligible. Patients with previous participation in a clinical trial can be included if they receive at least one subsequent therapy line in a routine clinical setting. Eligible systemic treatment includes all available anticancer therapies (approved, conditionally approved or provided through Early Access). Data collection includes biomarker testing results, demographics, baseline clinical characteristics, treatment details and effectiveness, safety information and imaging. Registry site inclusion is dependent on confirmation that local METex14 skipping detection methods are sufficient to confirm METex14 skipping status. MOMENT is currently active at more than 60 sites across Europe and North America and approximately 700 patients are expected to be enrolled within the next 4 years. The first patient was enrolled on 4 October 2022. After completion of data collection, MOMENT data can be shared with external parties to conduct non-interventional studies. Discussion/conclusion: The MOMENT registry collects comprehensive, high-quality real-world data from patients with METex14 skipping advanced NSCLC receiving systemic anticancer treatment in a routine clinical setting, to enable future studies informing regulatory decisions and optimal care for this rare population. Clinical Trial Registration: NCT05376891 (ClinicalTrials.gov); EUPAS47602 (EU PAS register no.).

Keywords: METex14 skipping; NSCLC; cancer registry; real-world data; targeted therapy.

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Conflict of interest statement

Competing interests disclosure

M Thomas: Honoraria/advisory board: Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Daiichi Sankyo, GlaxoSmithKline, Janssen Oncology, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda; research funding (institution): AstraZeneca, Bristol Myers Squibb, Merck, Roche, Takeda; non-financial support (travel costs): AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Janssen Oncology, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda. P Christopoulos: Research funding from Amgen, AstraZeneca, Boehringer Ingelheim, Merck, Novartis, Roche, Takeda; advisory board/lecture fees: AstraZeneca, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Gilead, Novartis, Pfizer, Roche, Takeda, Thermo Fisher Scientific. WT Iams: Consulting or advisory role: EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Janssen, Takeda, Bristol Myers Squibb, Mirati, Chardan Consulting, Curio Science, Defined Health, G1 Therapeutics, Genentech, Jazz Pharmaceuticals, Outcomes Insights. J Mazières: Advisory boards: Roche, Bristol Myers Squibb, MSD, AstraZeneca, Pfizer, Novartis, Merck, Amgen, Takeda, Daiichi Sankyo; research funding (institution): Roche/Genentech, AstraZeneca, Bristol Myers Squibb. AB Cortot: Research funding: Novartis, Merck; honoraria: AstraZeneca, Bristol Myers Squibb, Novartis, MSD, Pfizer, Roche, Takeda; consulting or advisory role: AstraZeneca, Bristol Myers Squibb, Novartis, Pfizer, Roche, Takeda; travel expenses: AstraZeneca, MSD, Novartis, Pfizer, Roche, Takeda. N Peled: Advisor, honoraria and research funding: Bristol Myers Squibb, Eli Lilly, Foundation Medicine, Guardant Health, Merck Serono Ltd., Herzliya, Israel, an affiliate of Merck KGaA, MSD, Novartis, NovellusDx, Pfizer, Roche, Takeda. G Minuti: Consulting/advisory role: AstraZeneca, Bristol Myers Squibb, Roche. EF Smit: Advisory/consultancy (institution): Lilly, AstraZeneca, Boehringer Ingelheim, Roche/Genentech, Bristol Myers Squibb, Merck, MSD, Takeda, Bayer, Regeneron, Novartis, Daiichi Sankyo, Seattle Genetics; research funding (institution): Boehringer Ingelheim, Bayer, Roche/Genentech, AstraZeneca, Bristol Myers Squibb. F Audhuy: Employee of Merck Serono S.A.S., Lyon, France, an affiliate of Merck KGaA. K Berghoff, F Fries, M Hildenbrand, SH Mahmoudpour, C Menzel, D Oksen: Employees of Merck. SP Eggleton: Employee of Merck Serono Ltd., Feltham, UK, an affiliate of Merck KGaA. P Liu: Employee of Merck Serono Pharmaceutical R&D Co., Ltd., Beijing, China, an affiliate of Merck KGaA. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.. Eligibility criteria.
aPrior to the initiation of a trial site, local METex14 skipping detection methods will be assessed. bPatients with previous participation in any clinical trial can be included, provided they receive at least one subsequent therapy line in a routine clinical setting. If a patient enters a clinical trial after enrollment into the registry, treatment will be blinded for data entry in the eCRF during the time the patient receives any investigational drug. cAll available anticancer therapies, including those approved, conditionally approved, or available through rearly access. dGiven as monotherapy or in combination with other systemic therapies. eCRF: Electronic case report form; ICI: Immune checkpoint inhibitor; LBx: Liquid biopsy; MET: Mesenchymal–epithelial transition factor, METex14: MET exon 14; NSCLC: Non-small-cell lung cancer; TBx: Tissue biopsy.
Figure 2.
Figure 2.. MOMENT registry participating countries.
EEA: European Economic Area.
Figure 3.
Figure 3.. Core data elements of the MOMENT registry.
aBased on tests performed to confirm biomarker status and genomic alterations (laboratory report data including test type, method, results, interpretation). bIncluding imaging needed to mimic RECIST v1.1 response assessment following clinical practice. Imaging data proposed to be sent to an independent review committee (if feasible) to independently assess tumor response (impact of any differences could be assessed during data analyses) per RECIST v1.1. ECOG PS: Eastern Cooperative Oncology Group Performance Status; MET: Mesenchymal–epithelial transition factor; METex14: MET exon 14; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Event; PD-L1: Programmed death-ligand 1: RECIST: Response Evaluation Criteria in Solid Tumors.
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References

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