Special Drug Use-results Surveillance of Tabrecta Tablets

Non-small Cell Lung Cancer Clinical Trial

Official title:

Special Drug Use-results Surveillance of Tabrecta Tablets (MET Exon 14 Skipping Mutation-positive Unresectable Advanced/Recurrent Non-small Cell Lung Cancer)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04575025
• Other study ID #: CINC280AJP01
• Status: Active, not recruiting
• Start date: November 2, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Tabrecta tablets
There is no treatment allocation. Patients administered Tabrecta by prescription that have started before inclusion of the patient into the study will be enrolled.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Akashi	Hyogo
Japan	Novartis Investigative Site	Aomori
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Daisen	Akita
Japan	Novartis Investigative Site	Edogawa	Tokyo
Japan	Novartis Investigative Site	Fujisawa	Kanagawa
Japan	Novartis Investigative Site	Fukui
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukushima city	Fukushima
Japan	Novartis Investigative Site	Hachinohe	Aomori
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Higashi-okitama	Yamagata
Japan	Novartis Investigative Site	Higashihiroshima	Hiroshima
Japan	Novartis Investigative Site	Himeji	Hyogo
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Iizuka	Fukuoka
Japan	Novartis Investigative Site	Izumo-city	Shimane
Japan	Novartis Investigative Site	Kanonji-city	Kagawa
Japan	Novartis Investigative Site	Kawaguchi	Saitama
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kishiwada-city	Osaka
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Konan	Aichi
Japan	Novartis Investigative Site	Koto ku	Tokyo
Japan	Novartis Investigative Site	Kumagaya	Saitama
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Matsumoto	Nagano
Japan	Novartis Investigative Site	Minato	Tokyo
Japan	Novartis Investigative Site	Minato ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Miyakonojo	Miyazaki
Japan	Novartis Investigative Site	Nagasaki-city	Nagasaki
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Ogaki-city	Gifu
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Okazaki-city	Aichi
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Saga-city	Saga
Japan	Novartis Investigative Site	Sagamihara	Kanagawa
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sakaide-city	Kagawa
Japan	Novartis Investigative Site	Sakura	Chiba
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Shibuya	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Takamatsu-city	Kagawa
Japan	Novartis Investigative Site	Tama	Tokyo
Japan	Novartis Investigative Site	Toyama-city	Toyama
Japan	Novartis Investigative Site	Toyoake city	Aichi
Japan	Novartis Investigative Site	Toyota	Aichi
Japan	Novartis Investigative Site	Tsu-city	Mie
Japan	Novartis Investigative Site	Tsuchiura	Ibaraki
Japan	Novartis Investigative Site	Tsukuba	Ibaraki
Japan	Novartis Investigative Site	Ube-city	Yamaguchi
Japan	Novartis Investigative Site	Yokkaichi	Mie
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yoshida-gun	Fukui

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse reactions	An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Tabrecta or whose causality is not recorded.	1 year
Primary	Response rate	A response rate is defined as a proportion of patients whose best overall response is CR or PR as assessed by the RECIST version 1.1(Eisenhauer et al. 2009). Patients assessed as not evaluable (NE) will be handled as non-responders, and included in the denominator for the calculation of response rates.	1 year
Primary	Overall survival rate	The Kaplan-Meier method will be used to estimate the survival curve. Overall survival is defined as the duration from the start date of Tabrecta administration to death of any cause. For patients surviving to the end, OS will be censored at the end date of the observation period.	1 year
Primary	Progression-free survival (PFS)	the Kaplan-Meier method will be used to estimate the PFS curve according to RECIST version 1.1 (Eisenhauer et al. 2009).; PFS is defined as the duration from the start date of Tabrecta administration to the date of the date of the first PD observed or death of any cause, whichever comes first. For patients without these events, PFS will be censored at the end date of the observation period.	1 year