Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
- Conditions
- Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation
- Registration Number
- NCT06161051
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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. Data abstraction was performed by the participating physician.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
-
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)
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world overall response rate (rwORR) 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) 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 progression-free survival (rwPFS) Up to approximately 5 years Time from start of therapy until the earliest of a clinically documented systemic disease progression.
Time-to-treatment discontinuation (TTD) Up to approximately 5 years Real-world duration of response (rwDOR) 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.
Overall survival (OS) Up to approximately 5 years Time from start of therapy until death.
- Secondary Outcome Measures
Name Time Method Number of patients per demographic category Baseline Demographic categories included sex, race/ethnicity, and insurance status.
Number of patients per clinical characteristic category Baseline Clinical characteristics included staging, presence and site(s) of metastases, number of lesions, and performance status.
Mean age Baseline Number of patients per comorbidity Up to 6 months pre-baseline
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States