Special Drug Use-results Surveillance of Tabrecta Tablets

NCT ID: NCT04575025

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-02

Study Completion Date

2024-10-26

Brief Summary

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This study was an uncontrolled, primary data collection-based observational study to be conducted as a central registration system, multicenter special drug-use results surveillance. As an all-case study, this study collected all patients treated with Tabrecta in a specified post-marketing period. The observation period of each patient was up to 1 year (52 weeks)

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tabrecta tablets

Patients administered Tabrecta by prescription

Tabrecta tablets

Intervention Type DRUG

There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled.

Interventions

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Tabrecta tablets

There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period

Exclusion Criteria

\-
Minimum Eligible Age

0 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Kōnan, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Okazaki, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Toyota, Aichi-ken, Japan

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Daisen, Akita, Japan

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Hachinohe, Aomori, Japan

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Sakura, Chiba, Japan

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Fukui-shi, Fukui, Japan

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Yoshida-gun, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Iizuka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Ōgaki, Gifu, Japan

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Higashihiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Himeji, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Tsuchiura, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kan’onjichō, Kagawa-ken, Japan

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Sakaidechō, Kagawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Fujisawa, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Tsu, Mie-ken, Japan

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Yokkaichi, Mie-ken, Japan

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Miyakonojō, Miyazaki, Japan

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Matsumoto, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Kurashiki, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Kishiwada, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Saga, Saga-ken, Japan

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Kawaguchi, Saitama, Japan

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Kumagaya, Saitama, Japan

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Saitama, Saitama, Japan

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Saitama, Saitama, Japan

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Izumo, Shimane, Japan

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Hamamatsu, Shizuoka, Japan

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Bunkyo Ku, Tokyo, Japan

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Chuo Ku, Tokyo, Japan

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Edogawa City, Tokyo, Japan

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Kiyose, Tokyo, Japan

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Koto Ku, Tokyo, Japan

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Minato, Tokyo, Japan

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Minato Ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Shibuya City, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Tama, Tokyo, Japan

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Toyama, Toyama, Japan

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Higashi Okitama, Yamagata, Japan

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Ube, Yamaguchi, Japan

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Aomori, , Japan

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Chiba, , Japan

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Hiroshima, , Japan

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Kumamoto, , Japan

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Kumamoto, , Japan

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Osaka, , Japan

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Countries

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Japan

Related Links

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Other Identifiers

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CINC280AJP01

Identifier Type: -

Identifier Source: org_study_id

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