Special Drug Use-results Surveillance of Tabrecta Tablets

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

ClinicalTrials.gov Identifier: NCT04575025

Novartis Reference Number: CINC280AJP01

Last Update: Nov 10, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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)

Condition 
Non-small Cell Lung Cancer
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
100 participants
Start date 
Nov 02, 2020
Completion date 
Sep 29, 2023
Gender 
All
Age(s)
99 Years and older (Child, Adult, Older Adult)

Interventions

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.

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:

-

Study Locations

Japan
Novartis Investigative Site
Recruiting
Nagoya, 464 8681
Aichi
Japan
Novartis Investigative Site
Recruiting
Daisen, 014-0027
Akita
Japan
Novartis Investigative Site
Recruiting
Sakura, 285-8741
Chiba
Japan
Novartis Investigative Site
Recruiting
Fukushima city, 960 1295
Fukushima
Japan
Novartis Investigative Site
Recruiting
Akashi, 673-8558
Hyogo
Japan
Novartis Investigative Site
Recruiting
Nishinomiya, 663 8501
Hyogo
Japan
Novartis Investigative Site
Recruiting
Fujisawa, 251-8550
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 241-8515
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 220-8521
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kumamoto City, 860-8556
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Matsumoto-city, 390-8621
Nagano
Japan
Novartis Investigative Site
Recruiting
Osaka-city, 541-8567
Osaka
Japan
Novartis Investigative Site
Recruiting
Kawaguchi, 332-8558
Saitama
Japan
Novartis Investigative Site
Recruiting
Sunto Gun, 411 8777
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Shimotsuga Gun, 321-0293
Tochigi
Japan
Novartis Investigative Site
Recruiting
Fukui, 918-8501
-
Japan
Novartis Investigative Site
Recruiting
Saitama, 330-8553
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]