Metastatic Non-Small Cell Lung CancerNCT05675683
Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
An observational study of Metastatic Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of metastatic NSCLC with MET Exon 14 skipping mutation and brain metastases (BM) who received treatment with capmatinib in real-world practice settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Capmatinib
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- Patient was aged ≥ 18 years at the time of NSCLC diagnosis
- Patient had histologically confirmed stage IIIB, IIIC, or IV NSCLC with MET Exon 14 skipping mutation at the time of initial NSCLC diagnosis
- Patient had ≥ 1 measurable intracranial lesion after initial diagnosis of BM
- Patient was treated with capmatinib after diagnosis of BM (any line)
Who cannot join
- Patients with characterized Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) mutations that predict sensitivity to epidermal growth factor receptor therapy, including but not limited to exon 19 deletions and exon 21 mutations
- Patients with other known actionable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to receive alternative targeted therapies
- Patients who had been treated with METis in any therapy line before or after the study index date
- Patients who had participated in a clinical trial related to treatment for NSCLC at any time before or after the study index date
Trial locations and contacts
1 site in 1 country.
United States1 site
18 Novartis Investigative Sites in the US
East Hanover, New Jersey, 07936-1080
About this study
This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of metastatic NSCLC with MET Exon 14 skipping mutation and brain metastases (BM) who received treatment with capmatinib in real-world practice settings.
The study population consisted of patients with histologically confirmed stage IIIB, IIIC, or IV MET Exon 14 skipping mutated NSCLC with BM. The date of the initiation of therapy with capmatinib after the date of initial BM diagnosis at or after the initial advanced or metastatic NSCLC diagnosis defined the study index date. The 12-month period before the study index date defined the baseline period to assess baseline demographic and clinical characteristics. Study measures were assessed at the index and during the baseline and postindex date periods. The index date needed to occur between 1 May 2020 and the date of data abstraction, provided the selected patients meet the requirement of a minimum of 6 months follow-up time available after capmatinib initiation; the exceptions to this are those patients who died during this period.
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Being tested
- Capmatinib
- 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.
CapmatinibDrug
Patients receiving Capmatinib
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Brain Metastases | Patients with Asymptomatic Brain Metastases Receives: Drug: Capmatinib | |
| Symptomatic Brain Metastases | Patient with Symptomatic Brain Metastases Receives: Drug: Capmatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-treatment discontinuation (TTD) from treatment initiation until discontinuation of capmatinib line of therapy or death, whichever was earlier
Measured: Up to 12 months
Secondary outcomes (5)
Real-world overall response rate (rwORR): Percentage of participants with best overall response of either a complete response (CR) or a partial response (PR) to the capmatinib line of therapy
rwORR was assessed per the pseudo-Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or as assessed by a healthcare professional (HCP), as available. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions. Best overall response consisted of CR+PR.
Measured: Up to approximately 23 months
Real-world disease control rate (rwDCR): Percentage of participants with best overall response to the capmatinib line of therapy of either CR+PR or stable disease (SD)
rwDCR was assessed per the pseudo-RECIST version 1.1 or as assessed by an HCP, as available.
Measured: Up to approximately 23 months
Real-world duration of response (rwDOR): Time from the date of first documented CR or PR to the first documented progression or death due to any cause
CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions.
Measured: Up to approximately 33 months
Real-world progression-free survival (rwPFS): Time from start of capmatinib therapy until the earliest of a clinically documented systemic disease progression
Measured: Up to 12 months
Overall survival (OS): Time from start of capmatinib therapy until death
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Retrospective
- Enrolment
- 68 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
- NCT05675683
- Sponsor's protocol ID
- CINC280AUS13
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
- ClinicalTrials.gov ID
- NCT05675683
- Acronym / sponsor ID
- CINC280AUS13
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Jan 2023 (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 was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of metastatic NSCLC with MET Exon 14 skipping mutation and brain metastases (BM) who received treatment with capmatinib in real-world practice settings.
The study population consisted of patients with histologically confirmed stage IIIB, IIIC, or IV MET Exon 14 skipping mutated NSCLC with BM. The date of the initiation of therapy with capmatinib after the date of initial BM diagnosis at or after the initial advanced or metastatic NSCLC diagnosis defined the study index date. The 12-month period before the study index date defined the baseline period to assess baseline demographic and clinical characteristics. Study measures were assessed at the index and during the baseline and postindex date periods. The index date needed to occur between 1 May 2020 and the date of data abstraction, provided the selected patients meet the requirement of a minimum of 6 months follow-up time available after capmatinib initiation; the exceptions to this are those patients who died during this period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Brain Metastases | – | Drug: CapmatinibPatients with Asymptomatic Brain Metastases |
| Symptomatic Brain Metastases | – | Drug: CapmatinibPatient with Symptomatic Brain Metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (4 listed)
- Patient was aged ≥ 18 years at the time of NSCLC diagnosis
- Patient had histologically confirmed stage IIIB, IIIC, or IV NSCLC with MET Exon 14 skipping mutation at the time of initial NSCLC diagnosis
- Patient had ≥ 1 measurable intracranial lesion after initial diagnosis of BM
- Patient was treated with capmatinib after diagnosis of BM (any line)
Key exclusion criteria (4 listed)
- Patients with characterized Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) mutations that predict sensitivity to epidermal growth factor receptor therapy, including but not limited to exon 19 deletions and exon 21 mutations
- Patients with other known actionable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to receive alternative targeted therapies
- Patients who had been treated with METis in any therapy line before or after the study index date
- Patients who had participated in a clinical trial related to treatment for NSCLC at any time before or after the study index date
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 |
|---|---|---|
| CapmatinibPatients receiving Capmatinib | Drug | Asymptomatic Brain Metastases, Symptomatic Brain Metastases |
Primary outcome
Time-to-treatment discontinuation (TTD) from treatment initiation until discontinuation of capmatinib line of therapy or death, whichever was earlier
Time frame: Up to 12 months
5 secondary outcomes
Real-world overall response rate (rwORR): Percentage of participants with best overall response of either a complete response (CR) or a partial response (PR) to the capmatinib line of therapy
Time frame: Up to approximately 23 months
Real-world disease control rate (rwDCR): Percentage of participants with best overall response to the capmatinib line of therapy of either CR+PR or stable disease (SD)
Time frame: Up to approximately 23 months
Real-world duration of response (rwDOR): Time from the date of first documented CR or PR to the first documented progression or death due to any cause
Time frame: Up to approximately 33 months
Real-world progression-free survival (rwPFS): Time from start of capmatinib therapy until the earliest of a clinically documented systemic disease progression
Time frame: Up to 12 months
Overall survival (OS): Time from start of capmatinib therapy until death
Time frame: Up to 12 months
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 9 Jan 2023.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
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 4 inclusion and 4 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Time-to-treatment discontinuation (TTD) from treatment initiation until discontinuation of capmatinib line of therapy or death, whichever was earlier (time frame: Up to 12 months). 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 9 Jan 2023.