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Completed
NCT05675683
Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
Conditions: Metastatic Non-Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Enrollment: 68
Sponsor: Novartis Pharmaceuticals
Location: United States
Summary
This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of metastatic NSCLC with MET Exon 14 skipping mutation and brain metastases (BM) who received treatment with capmatinib in real-world practice settings.The study population consisted of patients with histologically confirmed stage IIIB, IIIC, or IV MET Exon 14 skipping mutated NSCLC with BM.
The date of the initiation of therapy with capmatinib after the date of initial BM diagnosis at or after the initial advanced or metastatic NSCLC diagnosis defined the study index date.
The 12-month period before the study index date defined the baseline period to assess baseline demographic and clinical characteristics.
Study measures were assessed at the index and during the baseline and postindex date periods.
The index date needed to occur between 1 May 2020 and the date of data abstraction, provided the selected patients meet the requirement of a minimum of 6 months follow-up time available after capmatinib initiation; the exceptions to this are those patients who died during this period.
Eligibility Criteria
Inclusion CriteriaPatient was aged ≥ 18 years at the time of NSCLC diagnosisPatient had histologically confirmed stage IIIB, IIIC, or IV NSCLC with MET Exon 14 skipping mutation at the time of initial NSCLC diagnosisPatient had ≥ 1 measurable intracranial lesion after initial diagnosis of BMPatient was treated with capmatinib after diagnosis of BM (any line)Exclusion CriteriaPatients with characterized Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) mutations that predict sensitivity to epidermal growth factor receptor therapy, including but not limited to exon 19 deletions and exon 21 mutationsPatients with other known actionable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to receive alternative targeted therapiesPatients who had been treated with METis in any therapy line before or after the study index datePatients who had participated in a clinical trial related to treatment for NSCLC at any time before or after the study index date
Source: ClinicalTrials.gov (NCT05675683). StuddyBuddy aggregates publicly available trial information.