Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping MutationNCT06161051
Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
An observational study of Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation, 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 advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 7 Dec 2022
- 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.
- Had histologically confirmed advanced (stage IIIB, IIIC, or IV) NSCLC with MET exon 14 skipping mutation.
- Initiated first-line (1L) treatment for aNSCLC between 1 January 2017 and date of data abstraction with one of the following treatment regimen:
- Capmatinib
- IO agent in monotherapy (e.g., atezolizumab, pembrolizumab)
- CT regimen, single agent or combinations of CT agents (e.g., platinum agents, taxane agents, gemcitabine, pemetrexed)
Show all 9Show fewer
- Combination regimen containing IO and CT agents
- Had ≥ 6 months of potential follow-up time after the initiation of 1L treatment for aNSCLC, except if the patient died sooner.
- Living or deceased at the time of chart abstraction.
Who cannot join
- Presence of other mutations (e.g., EGFR, ALK, ROS1, RET, NTRK, BRAF, or KRAS) at any time.
- Treatment with other MET inhibitors such as crizotinib or tepotinib at any time during the study period.
- Participation in clinical trials related to treatment for NSCLC at any timepoint.
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Data abstraction was performed by the participating physician.
- Keywords
- aNSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Capmatinib | Not described | |
| IO monotherapy | Not described | |
| Chemotherapy alone | Not described | |
| IO + chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-treatment discontinuation (TTD)
Measured: Up to approximately 5 years
Real-world overall response rate (rwORR)
Proportion of patients with best overall response of either a complete response (CR) or partial response (PR) to the line of therapy based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or per healthcare professional (HCP) assessment.
Measured: Up to approximately 5 years
Real-world disease control rate (rwDCR)
Proportion of patients with best overall response of either a CR+PR or stable disease to the line of therapy based on RECIST version 1.1, or per HCP assessment.
Measured: Up to approximately 5 years
Real-world duration of response (rwDOR)
Time from the date of first documented CR or PR to the first documented systemic disease progression or death due to any cause.
Measured: Up to approximately 5 years
Real-world progression-free survival (rwPFS)
Time from start of therapy until the earliest of a clinically documented systemic disease progression.
Measured: Up to approximately 5 years
Overall survival (OS)
Time from start of therapy until death.
Measured: Up to approximately 5 years
Secondary outcomes (4)
Number of patients per demographic category
Demographic categories included sex, race/ethnicity, and insurance status.
Measured: Baseline
Mean age
Measured: Baseline
Number of patients per clinical characteristic category
Clinical characteristics included staging, presence and site(s) of metastases, number of lesions, and performance status.
Measured: Baseline
Number of patients per comorbidity
Measured: Up to 6 months pre-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start3 Oct 2022
- Primary completion2 Nov 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping MutationStudies 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
- 287 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
- NCT06161051
- Sponsor's protocol ID
- CINC280AUS16
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
- ClinicalTrials.gov ID
- NCT06161051
- Acronym / sponsor ID
- CINC280AUS16
- Keywords
- aNSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 7 Dec 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 advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Data abstraction was performed by the participating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Capmatinib | – | – |
| IO monotherapy | – | – |
| Chemotherapy alone | – | – |
| IO + chemotherapy | – | – |
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 (9 listed)
- Patient was aged ≥ 18 years at the time of NSCLC diagnosis.
- Had histologically confirmed advanced (stage IIIB, IIIC, or IV) NSCLC with MET exon 14 skipping mutation.
- Initiated first-line (1L) treatment for aNSCLC between 1 January 2017 and date of data abstraction with one of the following treatment regimen:
- Had ≥ 6 months of potential follow-up time after the initiation of 1L treatment for aNSCLC, except if the patient died sooner.
- Living or deceased at the time of chart abstraction.
Key exclusion criteria (3 listed)
- Presence of other mutations (e.g., EGFR, ALK, ROS1, RET, NTRK, BRAF, or KRAS) at any time.
- Treatment with other MET inhibitors such as crizotinib or tepotinib at any time during the study period.
- Participation in clinical trials related to treatment for NSCLC at any timepoint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time-to-treatment discontinuation (TTD)
Time frame: Up to approximately 5 years
Real-world overall response rate (rwORR)
Time frame: Up to approximately 5 years
Proportion of patients with best overall response of either a complete response (CR) or partial response (PR) to the line of therapy based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or per healthcare professional (HCP) assessment.
Real-world disease control rate (rwDCR)
Time frame: Up to approximately 5 years
Proportion of patients with best overall response of either a CR+PR or stable disease to the line of therapy based on RECIST version 1.1, or per HCP assessment.
Real-world duration of response (rwDOR)
Time frame: Up to approximately 5 years
Time from the date of first documented CR or PR to the first documented systemic disease progression or death due to any cause.
Real-world progression-free survival (rwPFS)
Time frame: Up to approximately 5 years
Time from start of therapy until the earliest of a clinically documented systemic disease progression.
Overall survival (OS)
Time frame: Up to approximately 5 years
Time from start of therapy until death.
4 secondary outcomes
Number of patients per demographic category
Time frame: Baseline
Mean age
Time frame: Baseline
Number of patients per clinical characteristic category
Time frame: Baseline
Number of patients per comorbidity
Time frame: Up to 6 months pre-baseline
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 7 Dec 2023.
Related trials for Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation
Active, not recruitingPhase 1
Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET
Advanced Solid Tumor, Metastatic Solid Tumors
RecruitingPhase 2
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Solid Tumors, Advanced 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
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 Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation, 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 9 inclusion and 3 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 7 Dec 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) (time frame: Up to approximately 5 years). The study lists 6 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 7 Dec 2023.