Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tabrecta tablets | Drug | Capmatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Tabrecta tablets
- description
- Patients administered Tabrecta by prescription
- interventionNames
- Drug: Tabrecta tablets
Primary outcomes (4)
- measure
- Number of patients with adverse reactions
- timeFrame
- 1 year
- description
- 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.
- measure
- Response rate
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available