Special Drug Use-results Surveillance of Tabrecta Tablets

NCT04575025 | Completed

• 1 other identifier: CINC280AJP01
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 78

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)

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; non-small cell lung cancer; MET exon 14 skipping mutation-positive

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Tabrecta tablets

Patients administered Tabrecta by prescription

Drug: Tabrecta tablets

Interventions

Tabrecta tablets DRUG

There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled.

Tabrecta tablets

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (78)

Novartis Investigative Site

Kōnan, Aichi-ken, 4838704, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 457-0818, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 462-0057, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 464 8681, Japan

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Novartis Investigative Site

Okazaki, Aichi-ken, 444-8553, Japan

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Novartis Investigative Site

Toyoake, Aichi-ken, 470 1192, Japan

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Novartis Investigative Site

Toyota, Aichi-ken, 470-0343, Japan

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Novartis Investigative Site

Daisen, Akita, 014-0027, Japan

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Novartis Investigative Site

Hachinohe, Aomori, 031-0011, Japan

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Novartis Investigative Site

Sakura, Chiba, 285-8741, Japan

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Novartis Investigative Site

Fukui-shi, Fukui, 918-8501, Japan

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Novartis Investigative Site

Yoshida-gun, Fukui, 910-1193, Japan

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Novartis Investigative Site

Fukuoka, Fukuoka, 811-1395, Japan

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Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

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Novartis Investigative Site

Fukuoka, Fukuoka, 814 0180, Japan

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Novartis Investigative Site

Iizuka, Fukuoka, 820-0076, Japan

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Kitakyushu, Fukuoka, 802-0077, Japan

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Novartis Investigative Site

Kitakyushu, Fukuoka, 8058508, Japan

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Novartis Investigative Site

Kitakyushu, Fukuoka, 806-8501, Japan

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Novartis Investigative Site

Fukushima, Fukushima, 960 1295, Japan

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Novartis Investigative Site

Ōgaki, Gifu, 503-8502, Japan

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Novartis Investigative Site

Higashihiroshima, Hiroshima, 739-0041, Japan

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Novartis Investigative Site

Sapporo, Hokkaido, 003-0804, Japan

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Novartis Investigative Site

Akashi, Hyōgo, 673-8558, Japan

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Novartis Investigative Site

Himeji, Hyōgo, 670-8520, Japan

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Novartis Investigative Site

Nishinomiya, Hyōgo, 663 8501, Japan

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Novartis Investigative Site

Tsuchiura, Ibaraki, 300-0028, Japan

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Novartis Investigative Site

Tsukuba, Ibaraki, 305-8558, Japan

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Novartis Investigative Site

Kan’onjichō, Kagawa-ken, 769-1695, Japan

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Novartis Investigative Site

Sakaidechō, Kagawa-ken, 762-8550, Japan

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Takamatsu, Kagawa-ken, 760-0017, Japan

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Novartis Investigative Site

Fujisawa, Kanagawa, 251-8550, Japan

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Kawasaki, Kanagawa, 216-8511, Japan

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Sagamihara, Kanagawa, 252-0375, Japan

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Yokohama, Kanagawa, 220-8521, Japan

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Yokohama, Kanagawa, 221-0855, Japan

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Novartis Investigative Site

Yokohama, Kanagawa, 232 0024, Japan

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Novartis Investigative Site

Yokohama, Kanagawa, 234-0054, Japan

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Novartis Investigative Site

Yokohama, Kanagawa, 236 0037, Japan

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Novartis Investigative Site

Tsu, Mie-ken, 514-8507, Japan

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Novartis Investigative Site

Yokkaichi, Mie-ken, 510-8567, Japan

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Novartis Investigative Site

Miyakonojō, Miyazaki, 885-0014, Japan

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Novartis Investigative Site

Matsumoto, Nagano, 390-8621, Japan

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Novartis Investigative Site

Nagasaki, Nagasaki, 852-8501, Japan

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Novartis Investigative Site

Kurashiki, Okayama-ken, 701-0192, Japan

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Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

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Novartis Investigative Site

Kishiwada, Osaka, 596-8501, Japan

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Osaka, Osaka, 534-0021, Japan

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Novartis Investigative Site

Osaka, Osaka, 540-0006, Japan

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Novartis Investigative Site

Osaka, Osaka, 541-8567, Japan

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Novartis Investigative Site

Osaka, Osaka, 543-8555, Japan

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Novartis Investigative Site

Saga, Saga-ken, 849-8501, Japan

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Novartis Investigative Site

Kawaguchi, Saitama, 332-8558, Japan

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Novartis Investigative Site

Kumagaya, Saitama, 360-0197, Japan

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Novartis Investigative Site

Saitama, Saitama, 330 8503, Japan

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Novartis Investigative Site

Saitama, Saitama, 330-8553, Japan

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Novartis Investigative Site

Izumo, Shimane, 693 8501, Japan

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Novartis Investigative Site

Hamamatsu, Shizuoka, 431-3192, Japan

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Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

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Novartis Investigative Site

Chuo Ku, Tokyo, 104 0045, Japan

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Novartis Investigative Site

Edogawa City, Tokyo, 133-0052, Japan

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Novartis Investigative Site

Kiyose, Tokyo, 204-8585, Japan

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Novartis Investigative Site

Koto Ku, Tokyo, 135 8550, Japan

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Novartis Investigative Site

Minato, Tokyo, 108-0073, Japan

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Novartis Investigative Site

Minato Ku, Tokyo, 105-8470, Japan

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Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

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Novartis Investigative Site

Shibuya City, Tokyo, 150-8935, Japan

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Novartis Investigative Site

Shinjuku Ku, Tokyo, 160-0023, Japan

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Novartis Investigative Site

Tama, Tokyo, 206-8512, Japan

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Novartis Investigative Site

Toyama, Toyama, 930-0194, Japan

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Novartis Investigative Site

Higashi Okitama, Yamagata, 9920601, Japan

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Novartis Investigative Site

Ube, Yamaguchi, 755-0241, Japan

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Novartis Investigative Site

Aomori, 030 8553, Japan

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Novartis Investigative Site

Chiba, 261-0001, Japan

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Novartis Investigative Site

Hiroshima, 734 8530, Japan

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Novartis Investigative Site

Kumamoto, 860-8556, Japan

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Novartis Investigative Site

Kumamoto, 861-4193, Japan

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Novartis Investigative Site

Osaka, 530 0005, Japan

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: November 2, 2020
• Primary Completion: October 26, 2024
• Study Completion: October 26, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (78)