Clinical trial NCT04575025: Special Drug Use-results Surveillance of Tabrecta Tablets
Official title: Special Drug Use-results Surveillance of Tabrecta Tablets (MET Exon 14 Skipping Mutation-positive Unresectable Advanced/Recurrent Non-small Cell Lung Cancer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
non-small cell lung cancer
MET exon 14 skipping mutation-positive
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 109
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period. By allowing patients who started Tabrecta administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Tabrecta will be enrolled in this study.

Brief summary: This study is 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 will collect all patients treated with Tabrecta in a specified post-marketing period. The observation period of each patient is up to 1 year (52 weeks)


Eligibility criteria: 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:

-

Primary outcomes:
measure: Number of patients with adverse reactions
timeFrame: 1 year
measure: Response rate
timeFrame: 1 year
measure: Overall survival rate
timeFrame: 1 year
measure: Progression-free survival (PFS)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Konan
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Okazaki
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyoake city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyota
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Daisen
country: Japan
facility: Novartis Investigative Site
state: Akita
city: Hachinohe
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Sakura
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yoshida-gun
country: Japan
facility: Novartis Investigative Site
state: Fukui
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Iizuka
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukushima city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Ogaki-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Higashihiroshima
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Akashi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Tsuchiura
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanonji-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Sakaide-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Fujisawa
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Tsu-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Yokkaichi
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Miyakonojo
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Matsumoto
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Nagasaki-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kishiwada-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Saga-city
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Kawaguchi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kumagaya
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Izumo-city
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tama
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Higashi Okitama
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Ube-city
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Aomori
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukui
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: