Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, non-small cell lung cancer, MET exon 14 skipping mutation-positive
Brief summary
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)
Interventions
DRUGTabrecta tablets
There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 99 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) were handled as non-responders, and included in the denominator for the calculation of response rates. |
| Overall survival rate | 1 year | The Kaplan-Meier method was 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 was censored at the end date of the observation period. |
| Progression-free survival (PFS) | 1 year | the Kaplan-Meier method was 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 was censored at the end date of the observation period. |
Countries
Japan
Outcome results
None listed