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)

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: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Tabrecta tablets

• Study Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse reactions	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	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	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)	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

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Link to study results

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): October 26, 2024
• Study Completion (Actual): October 26, 2024

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; non-small cell lung cancer; MET exon 14 skipping mutation-positive
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; capmatinib
• Other Study ID 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