Special Drug Use-results Surveillance of Tabrecta Tablets

September 8, 2025 updated by: Novartis Pharmaceuticals

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novartis Pharmaceuticals

Study Contact Backup

Study Locations

  • Japan
      • Aomori, Japan, 030 8553
        • Novartis Investigative Site
      • Chiba, Japan, 261-0001
        • Novartis Investigative Site
      • Hiroshima, Japan, 734 8530
        • Novartis Investigative Site
      • Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
      • Kumamoto, Japan, 861-4193
        • Novartis Investigative Site
      • Osaka, Japan, 530 0005
        • Novartis Investigative Site
    • Aichi-ken
      • Kōnan, Aichi-ken, Japan, 4838704
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 464 8681
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 457-0818
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 462-0057
        • Novartis Investigative Site
      • Okazaki, Aichi-ken, Japan, 444-8553
        • Novartis Investigative Site
      • Toyoake, Aichi-ken, Japan, 470 1192
        • Novartis Investigative Site
      • Toyota, Aichi-ken, Japan, 470-0343
        • Novartis Investigative Site
    • Akita
      • Daisen, Akita, Japan, 014-0027
        • Novartis Investigative Site
    • Aomori
      • Hachinohe, Aomori, Japan, 031-0011
        • Novartis Investigative Site
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Novartis Investigative Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 918-8501
        • Novartis Investigative Site
      • Yoshida-gun, Fukui, Japan, 910-1193
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Novartis Investigative Site
      • Fukuoka, Fukuoka, Japan, 814 0180
        • Novartis Investigative Site
      • Iizuka, Fukuoka, Japan, 820-0076
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 802-0077
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 8058508
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 806-8501
        • Novartis Investigative Site
    • Fukushima
      • Fukushima, Fukushima, Japan, 960 1295
        • Novartis Investigative Site
    • Gifu
      • Ōgaki, Gifu, Japan, 503-8502
        • Novartis Investigative Site
    • Hiroshima
      • Higashihiroshima, Hiroshima, Japan, 739-0041
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Novartis Investigative Site
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Novartis Investigative Site
      • Himeji, Hyōgo, Japan, 670-8520
        • Novartis Investigative Site
      • Nishinomiya, Hyōgo, Japan, 663 8501
        • Novartis Investigative Site
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Novartis Investigative Site
      • Tsukuba, Ibaraki, Japan, 305-8558
        • Novartis Investigative Site
    • Kagawa-ken
      • Kan’onjichō, Kagawa-ken, Japan, 769-1695
        • Novartis Investigative Site
      • Sakaidechō, Kagawa-ken, Japan, 762-8550
        • Novartis Investigative Site
      • Takamatsu, Kagawa-ken, Japan, 760-0017
        • Novartis Investigative Site
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 251-8550
        • Novartis Investigative Site
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Novartis Investigative Site
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 234-0054
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 221-0855
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 220-8521
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 236 0037
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 232 0024
        • Novartis Investigative Site
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Novartis Investigative Site
      • Yokkaichi, Mie-ken, Japan, 510-8567
        • Novartis Investigative Site
    • Miyazaki
      • Miyakonojō, Miyazaki, Japan, 885-0014
        • Novartis Investigative Site
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Novartis Investigative Site
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 701-0192
        • Novartis Investigative Site
      • Okayama, Okayama-ken, Japan, 700-8558
        • Novartis Investigative Site
    • Osaka
      • Kishiwada, Osaka, Japan, 596-8501
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 540-0006
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 534-0021
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 541-8567
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 543-8555
        • Novartis Investigative Site
    • Saga-ken
      • Saga, Saga-ken, Japan, 849-8501
        • Novartis Investigative Site
    • Saitama
      • Kawaguchi, Saitama, Japan, 332-8558
        • Novartis Investigative Site
      • Kumagaya, Saitama, Japan, 360-0197
        • Novartis Investigative Site
      • Saitama, Saitama, Japan, 330 8503
        • Novartis Investigative Site
      • Saitama, Saitama, Japan, 330-8553
        • Novartis Investigative Site
    • Shimane
      • Izumo, Shimane, Japan, 693 8501
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 113-8431
        • Novartis Investigative Site
      • Chuo Ku, Tokyo, Japan, 104 0045
        • Novartis Investigative Site
      • Edogawa City, Tokyo, Japan, 133-0052
        • Novartis Investigative Site
      • Kiyose, Tokyo, Japan, 204-8585
        • Novartis Investigative Site
      • Koto Ku, Tokyo, Japan, 135 8550
        • Novartis Investigative Site
      • Minato, Tokyo, Japan, 108-0073
        • Novartis Investigative Site
      • Minato Ku, Tokyo, Japan, 105-8470
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-8471
        • Novartis Investigative Site
      • Shibuya City, Tokyo, Japan, 150-8935
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 160-0023
        • Novartis Investigative Site
      • Tama, Tokyo, Japan, 206-8512
        • Novartis Investigative Site
    • Toyama
      • Toyama, Toyama, Japan, 930-0194
        • Novartis Investigative Site
    • Yamagata
      • Higashi Okitama, Yamagata, Japan, 9920601
        • Novartis Investigative Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0241
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period. By allowing patients who started Tabrecta administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Tabrecta were enrolled in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tabrecta tablets
Patients administered Tabrecta by prescription
Drug: Tabrecta tablets
There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with adverse reactions
Time Frame: 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.
1 year
Response rate
Time Frame: 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.
1 year
Overall survival rate
Time Frame: 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.
1 year
Progression-free survival (PFS)
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CINC280AJP01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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