Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 287
- Locations
- 1
- Primary Endpoint
- Real-world overall response rate (rwORR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 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.
Time-to-treatment discontinuation (TTD)
Time Frame: Up to approximately 5 years
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.
Overall survival (OS)
Time Frame: Up to approximately 5 years
Time from start of therapy until death.
Secondary Outcomes
- Number of patients per demographic category(Baseline)
- Number of patients per clinical characteristic category(Baseline)
- Mean age(Baseline)
- Number of patients per comorbidity(Up to 6 months pre-baseline)