Evidence map›Paper›PMID 33506571›Full record

Trial reportCancer science2021

Capmatinib in Japanese patients with MET exon 14 skipping-mutated or MET-amplified advanced NSCLC: GEOMETRY mono-1 study.

Takashi Seto, Kadoaki Ohashi, Shunichi Sugawara, Makoto Nishio, Masayuki Takeda, Keisuke Aoe, Sanae Moizumi, Satoshi Nomura, Takeshi Tajima, Toyoaki Hida

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02414139 (A Phase II, Multicenter Study of Oral MET Inhibitor INC280 in Adult Patients With EGFR Wild-type), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT02414139 phase2completednot on this map

A Phase II, Multicenter Study of Oral MET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2023Enrolled373ConditionsCarcinoma, Non-Small-Cell LungArmsCapmatinib
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Efficacy and safety analysis of immunotherapy in non-small cell lung cancer patients with MET alterations.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. New Targeted Therapy for Non-Small Cell Lung Cancer.Tuberculosis and respiratory diseases · 2023
    Article
  13. Article
  14. Article
  15. Article
  16. Article
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

10 authors at 8 institutions in 1 country.

Takashi SetoDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kadoaki OhashiDepartment of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Shunichi SugawaraSendai Kousei Hospital, Miyagi, Japan.
Makoto NishioThoracic Center, Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID https://orcid.org/0000-0003-4969-4165
Masayuki TakedaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
Keisuke AoeDepartment of Medical Oncology, National Hospital Organization Yamaguchi-Ube Medical Center, Yamaguchi, Japan.
Sanae MoizumiDevelopment Division, Novartis Pharma K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0001-5853-1435
Satoshi NomuraDevelopment Division, Novartis Pharma K.K., Tokyo, Japan.
Takeshi TajimaDevelopment Division, Novartis Pharma K.K., Tokyo, Japan.
Toyoaki HidaDepartment of Thoracic Oncology, Aichi Cancer Center Hospital, Aichi, Japan.ORCID https://orcid.org/0000-0003-3537-0020
Novartis (Japan) · JPAichi Cancer Center · JPKindai University · JPNational Hospital Organization Kyushu Cancer Center · JPNational Sanyo Hospital · JPOkayama University Hospital · JPSendai Kousei Hospital · JPThe Cancer Institute Hospital · JP

Funding

Novartis
6 · The paper itself

Abstract

MET mutations leading to exon 14 skipping (METΔex14) are strong molecular drivers for non-small-cell lung cancer (NSCLC). Capmatinib is a highly potent, selective oral MET inhibitor that showed clinically meaningful efficacy and a manageable safety profile in a global phase II study (GEOMETRY mono-1, NCT02414139) in patients with advanced METΔex14-mutated/MET-amplified NSCLC. We report results of preplanned analyses of 45 Japanese patients according to MET status (METΔex14-mutated or MET-amplified) and line of therapy (first- [1L] or second-/third-line [2/3L]). The starting dose was 400 mg twice daily. The primary endpoint was the objective response rate (ORR) assessed by a blinded independent review committee. A key secondary endpoint was duration of response (DOR). Among METΔex14-mutated patients, in the 1L group, one patient achieved partial response (DOR of 4.24 months) and the other had stable disease. In the 2/3L group, the ORR was 36.4% (95% confidence interval [CI] 10.9%-69.2%), median DOR was not evaluable, and progression-free survival was 4.70 months. One patient (2/3L group) showed partial resolution of brain lesions per independent neuroradiologist review. In MET-amplified patients with a MET gene copy number of ≥10, the ORR was 100% (2/2 patients) in the 1L group and 45.5% (5/11 patients) in the 2/3L group, with DOR of 8.2 and 8.3 months, respectively. Common treatment-related adverse events among the 45 Japanese patients were blood creatinine increased (53.3%), nausea (35.6%), and oedema peripheral (31.1%); most were grade 1/2 severity. In conclusion, capmatinib was effective and well tolerated by Japanese patients with METΔex14/MET-amplified NSCLC, consistent with the overall population.

Indexed as

AgedAged, 80 and overBenzamidesCarcinoma, Non-Small-Cell LungExonsFemaleHumansImidazolesJapanLung NeoplasmsMaleMutationProtein Kinase InhibitorsProto-Oncogene Proteins c-metTriazinesBenzamidescapmatinibImidazolesMET protein, humanProtein Kinase InhibitorsProto-Oncogene Proteins c-metTriazinescapmatinibMET receptor tyrosine kinasenon-small-cell lung cancerresponsesafety

Identifiers

PMID33506571
PMCPMC8019204
OpenAlexW3121929913

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.