Evidence map›Paper›PMID 38758397›Full record

Trial reportInternational journal of clinical oncology2024

Phase 2 trial of crizotinib in Japanese patients with advanced NSCLC harboring a MET gene alteration: a Co-MET study.

Kaname Nosaki, Kiyotaka Yoh, Ryo Toyozawa, Hidehito Horinouchi, Masahiro Morise, Kadoaki Ohashi, Haruyasu Murakami, Miyako Satouchi, Jun Sakakibara-Konishi, Seiji Yano and 5 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
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

15 authors.

Kaname NosakiDepartment of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Kiyotaka YohDepartment of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. kyoh@east.ncc.go.jp.ORCID http://orcid.org/0000-0001-6928-357X
Ryo ToyozawaDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Hidehito HorinouchiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Masahiro MoriseDepartment of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Kadoaki OhashiDepartment of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Haruyasu MurakamiDivision of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Miyako SatouchiDepartment of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan.
Jun Sakakibara-KonishiDepartment of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Seiji YanoDepartment of Respiratory Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan.
Fumihiko OkumuraDepartment of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Shingo MatsumotoDepartment of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Takashi SetoDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Koichi GotoDepartment of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.

Funding

Japan Agency for Medical Research and Development 17ck0106294h0001
6 · The paper itself

Abstract

backgroundMET exon 14 skipping mutations occur in 3-4% and MET high amplifications occur in < 1% of patients with non-small-cell lung cancer (NSCLC). Crizotinib, a selective ATP-competitive small-molecule inhibitor of c-Met, ALK, and ROS1 tyrosine kinases, has shown activity in cancer models with various types of MET activation.

methodsThe Co-MET study is a single-arm phase 2 trial to assess the safety and efficacy of crizotinib in MET inhibitor-naïve patients with advanced NSCLC harboring MET exon 14 skipping mutation (cohort 1) or high MET gene copy number of ≥ 7 (cohort 2). The primary endpoint was the objective response rate (ORR) per RECIST v1.1 by independent radiology review in cohort 1. The key secondary endpoints were the duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.

resultsA total of 28 patients (23 in cohort 1 and 5 in cohort 2) were enrolled between March 2018 and February 2020. The primary endpoint was met as the ORR (90% confidence interval: CI) in cohort 1 was 38.1% (20.6-58.3). Median DoR, PFS, and OS (95% CI) were 7.6 (1.9-NE), 5.7 (2.1-11.3), 9.1 (4.0-19.9) months, respectively, in cohort 1. ORR in cohort 2 was 40.0% (18.9-92.4). The safety signals were generally consistent with the known safety profile of crizotinib.

conclusionsCrizotinib showed a clinical activity similar to that of tepotinib and capmatinib in patients with NSCLC harboring MET exon 14 skipping mutations. CLINICAL TRIAL INFORMATION: UMIN000031623.

Indexed as

Carcinoma, Non-Small-Cell LungCrizotinibLung NeoplasmsMutationProto-Oncogene Proteins c-metAdultAgedEast Asian PeopleExonsFemaleHumansJapanMaleMiddle AgedProgression-Free SurvivalProtein Kinase InhibitorsCrizotinibMET protein, humanProtein Kinase InhibitorsProto-Oncogene Proteins c-metCrizotinibLung cancerMET amplificationMET exon 14 skipping mutation

Identifiers

PMID38758397

What OpenQuestion holds

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Registered trials

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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.