Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib

Completed

• Conditions: Metastatic Non-Small Cell Lung Cancer
• Interventions: Drug: Capmatinib

• Registration Number: NCT05675683
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic Brain Metastases	Capmatinib	Patient with Symptomatic Brain Metastases
Asymptomatic Brain Metastases	Capmatinib	Patients with Asymptomatic Brain Metastases

Primary Outcome Measures

Name	Time	Method
Time-to-treatment discontinuation (TTD) from treatment initiation until discontinuation of capmatinib line of therapy or death, whichever was earlier	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Real-world duration of response (rwDOR): Time from the date of first documented CR or PR to the first documented progression or death due to any cause	Up to approximately 33 months	CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions.
Real-world overall response rate (rwORR): Percentage of participants with best overall response of either a complete response (CR) or a partial response (PR) to the capmatinib line of therapy	Up to approximately 23 months	rwORR was assessed per the pseudo-Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or as assessed by a healthcare professional (HCP), as available. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions. Best overall response consisted of CR+PR.
Real-world disease control rate (rwDCR): Percentage of participants with best overall response to the capmatinib line of therapy of either CR+PR or stable disease (SD)	Up to approximately 23 months	rwDCR was assessed per the pseudo-RECIST version 1.1 or as assessed by an HCP, as available.
Real-world progression-free survival (rwPFS): Time from start of capmatinib therapy until the earliest of a clinically documented systemic disease progression	Up to 12 months
Overall survival (OS): Time from start of capmatinib therapy until death	Up to 12 months

Trial Locations

Locations (1)

18 Novartis Investigative Sites in the US; 🇺🇸 East Hanover, New Jersey, United States