Special Drug Use-results Surveillance of Tabrecta Tablets

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Tabrecta tablets

• Registration Number: NCT04575025
• Lead Sponsor: Novartis Pharmaceuticals

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2020-11-02
• Primary Completion: 2024-10-26
• Study Completion: 2024-10-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tabrecta tablets	Tabrecta tablets	Patients administered Tabrecta by prescription

Primary Outcome Measures

Name	Time	Method
Overall survival rate	1 year	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.
Number of patients with adverse reactions	1 year	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.
Progression-free survival (PFS)	1 year	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.
Response rate	1 year	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Toyama, Japan