Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation
Conditions
Keywords
aNSCLC
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 5 years | Time from start of therapy until death. |
| 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 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. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean age | Baseline | — |
| Number of patients per clinical characteristic category | Baseline | Clinical characteristics included staging, presence and site(s) of metastases, number of lesions, and performance status. |
| Number of patients per comorbidity | Up to 6 months pre-baseline | — |
| Number of patients per demographic category | Baseline | Demographic categories included sex, race/ethnicity, and insurance status. |
Countries
United States
Outcome results
None listed