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NCT04460729

A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases

Withdrawn Phase 2 Last updated 3 December 2020
What this trial tests

Phase 2 trial testing Capmatinib in Non-small Cell Lung Carcinoma (NSCLC). Withdrawn.

Timeline
11 November 2020
Primary endpoint
17 November 2023
17 November 2023

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Start date11 November 2020
Primary completion17 November 2023
Estimated completion17 November 2023

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Carcinoma (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to establish the intracranial efficacy of single agent capmatinib in the population of treatment-naïve or pretreated with one or two prior lines of systemic therapies for advanced stage Non Small-Cell Lung Cancer (NSCLC) with MET exon 14 mutation that has metastasized to the brain. Cohort 1 (asymptomatic brain metastases (BM) without prior brain therapy) has been selected to identify patients who are most likely to benefit from capmatinib therapy in this setting and to establish a clinically relevant response outcome. Cohort 2 is a heterogeneous group of patients (symptomatic with and without prior brain therapy, asymptomatic with prior brain therapy, or with leptomeningeal disease.), and the outcomes will be descriptive only

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current and future treatment options for <i>MET</i> exon 14 skipping alterations in non-small cell lung cancer.
    Hong L, Zhang J, Heymach JV, Le X. · · 2021 · cited 50× · PMID 33643443 · DOI 10.1177/1758835921992976
  2. The progress of microenvironment-targeted therapies in brain metastases.
    Long L, Yi Z, Zeng Y, Liu Z. · · 2023 · cited 4× · PMID 37056723 · DOI 10.3389/fmolb.2023.1141994
  3. Recent advances in the treatment of non-small cell lung cancer with MET inhibitors.
    Zhang D, Zhang W, Liu H, Liu P, et al · · 2024 · cited 1× · PMID 39720556 · DOI 10.3389/fchem.2024.1501844
  4. Targeting MET in non-small cell lung cancer brain metastases: from molecular mechanism to precision therapy.
    Wang X, Chi Y, Mu F, Mao H, et al · · 2026 · PMID 41981677 · DOI 10.1186/s12967-026-08077-2
  5. The global landscape of clinical trials and drug discovery for brain metastasis.
    Ding J, Jiang Y, Zhou J, Tang Q, et al · · 2024 · PMID 39107814 · DOI 10.1186/s12967-024-05310-8

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04460729.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing