Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States

Conditions
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Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Capmatinib<br> | |
| IO monotherapy<br> | |
| Chemotherapy alone<br> | |
| IO + chemotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-treatment discontinuation (TTD) |  | 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. | 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. | 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. | 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. | Up to approximately 5 years | 
| Overall survival (OS) | Time from start of therapy until death. | Up to approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients per demographic category | Demographic categories included sex, race/ethnicity, and insurance status. | Baseline | 
| Mean age |  | Baseline | 
| Number of patients per clinical characteristic category | Clinical characteristics included staging, presence and site(s) of metastases, number of lesions, and performance status. | Baseline | 
| Number of patients per comorbidity |  | Up to 6 months pre-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aNSCLC