Non-small Cell Lung CancerNCT04575025
Special Drug Use-results Surveillance of Tabrecta Tablets
An observational study of Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 78 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Tabrecta tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 109 participants
- Where
- 78 sitesJapan
- Study dates
- 2 Nov 2020to 26 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period
Who cannot join
- -
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
Japan78 sites
Novartis Investigative Site
Akashi, Hyōgo, 673-8558
Novartis Investigative Site
Aomori, 030 8553
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113-8431
Novartis Investigative Site
Chiba, 261-0001
Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045
Novartis Investigative Site
Daisen, Akita, 014-0027
Novartis Investigative Site
Edogawa City, Tokyo, 133-0052
Novartis Investigative Site
Fujisawa, Kanagawa, 251-8550
Novartis Investigative Site
Fukui-shi, Fukui, 918-8501
Novartis Investigative Site
Fukuoka, Fukuoka, 811-1395
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Fukuoka, Fukuoka, 814 0180
Novartis Investigative Site
Fukushima, Fukushima, 960 1295
Novartis Investigative Site
Hachinohe, Aomori, 031-0011
Novartis Investigative Site
Hamamatsu, Shizuoka, 431-3192
Novartis Investigative Site
Higashi Okitama, Yamagata, 9920601
Novartis Investigative Site
Higashihiroshima, Hiroshima, 739-0041
Novartis Investigative Site
Himeji, Hyōgo, 670-8520
Novartis Investigative Site
Hiroshima, 734 8530
Novartis Investigative Site
Iizuka, Fukuoka, 820-0076
Novartis Investigative Site
Izumo, Shimane, 693 8501
Novartis Investigative Site
Kan’onjichō, Kagawa-ken, 769-1695
Novartis Investigative Site
Kawaguchi, Saitama, 332-8558
Novartis Investigative Site
Kawasaki, Kanagawa, 216-8511
Novartis Investigative Site
Kishiwada, Osaka, 596-8501
Novartis Investigative Site
Kitakyushu, Fukuoka, 802-0077
Novartis Investigative Site
Kitakyushu, Fukuoka, 8058508
Novartis Investigative Site
Kitakyushu, Fukuoka, 806-8501
Novartis Investigative Site
Kiyose, Tokyo, 204-8585
Novartis Investigative Site
Kōnan, Aichi-ken, 4838704
Novartis Investigative Site
Koto Ku, Tokyo, 135 8550
Novartis Investigative Site
Kumagaya, Saitama, 360-0197
Novartis Investigative Site
Kumamoto, 860-8556
Novartis Investigative Site
Kumamoto, 861-4193
Novartis Investigative Site
Kurashiki, Okayama-ken, 701-0192
Novartis Investigative Site
Matsumoto, Nagano, 390-8621
Novartis Investigative Site
Minato, Tokyo, 108-0073
Novartis Investigative Site
Minato Ku, Tokyo, 105-8470
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Novartis Investigative Site
Miyakonojō, Miyazaki, 885-0014
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8501
Novartis Investigative Site
Nagoya, Aichi-ken, 457-0818
Novartis Investigative Site
Nagoya, Aichi-ken, 462-0057
Novartis Investigative Site
Nagoya, Aichi-ken, 464 8681
Novartis Investigative Site
Nishinomiya, Hyōgo, 663 8501
Novartis Investigative Site
Ōgaki, Gifu, 503-8502
Novartis Investigative Site
Okayama, Okayama-ken, 700-8558
Novartis Investigative Site
Okazaki, Aichi-ken, 444-8553
Novartis Investigative Site
Osaka, Osaka, 534-0021
Novartis Investigative Site
Osaka, Osaka, 540-0006
Novartis Investigative Site
Osaka, Osaka, 541-8567
Novartis Investigative Site
Osaka, Osaka, 543-8555
Novartis Investigative Site
Osaka, 530 0005
Novartis Investigative Site
Saga, Saga-ken, 849-8501
Novartis Investigative Site
Sagamihara, Kanagawa, 252-0375
Novartis Investigative Site
Saitama, Saitama, 330 8503
Novartis Investigative Site
Saitama, Saitama, 330-8553
Novartis Investigative Site
Sakaidechō, Kagawa-ken, 762-8550
Novartis Investigative Site
Sakura, Chiba, 285-8741
Novartis Investigative Site
Sapporo, Hokkaido, 003-0804
Novartis Investigative Site
Shibuya City, Tokyo, 150-8935
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0023
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760-0017
Novartis Investigative Site
Tama, Tokyo, 206-8512
Novartis Investigative Site
Toyama, Toyama, 930-0194
Novartis Investigative Site
Toyoake, Aichi-ken, 470 1192
Novartis Investigative Site
Toyota, Aichi-ken, 470-0343
Novartis Investigative Site
Tsu, Mie-ken, 514-8507
Novartis Investigative Site
Tsuchiura, Ibaraki, 300-0028
Novartis Investigative Site
Tsukuba, Ibaraki, 305-8558
Novartis Investigative Site
Ube, Yamaguchi, 755-0241
Novartis Investigative Site
Yokkaichi, Mie-ken, 510-8567
Novartis Investigative Site
Yokohama, Kanagawa, 220-8521
Novartis Investigative Site
Yokohama, Kanagawa, 221-0855
Novartis Investigative Site
Yokohama, Kanagawa, 232 0024
Novartis Investigative Site
Yokohama, Kanagawa, 234-0054
Novartis Investigative Site
Yokohama, Kanagawa, 236 0037
Novartis Investigative Site
Yoshida-gun, Fukui, 910-1193
About this study
Official title: 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)
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Tabrecta tablets
- Keywords
- NSCLC, non-small cell lung cancer, MET exon 14 skipping mutation-positive
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tabrecta tabletsDrug
There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Tabrecta tablets | Patients administered Tabrecta by prescription Receives: Drug: Tabrecta tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start2 Nov 2020
- Primary completion26 Oct 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575025
- Sponsor's protocol ID
- CINC280AJP01
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use-results Surveillance of Tabrecta Tablets (MET Exon 14 Skipping Mutation-positive Unresectable Advanced/Recurrent Non-small Cell Lung Cancer)
- ClinicalTrials.gov ID
- NCT04575025
- Acronym / sponsor ID
- CINC280AJP01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, non-small cell lung cancer, MET exon 14 skipping mutation-positive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tabrecta tablets | – | Drug: Tabrecta tabletsPatients administered Tabrecta by prescription |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tabrecta tabletsThere was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled. | Drug | Tabrecta tablets |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 78 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse reactions (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.