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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Capmatinib

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • 18 Novartis Investigative Sites in the US

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria

• Patient was aged ≥ 18 years at the time of NSCLC diagnosis
• Patient had histologically confirmed stage IIIB, IIIC, or IV NSCLC with MET Exon 14 skipping mutation at the time of initial NSCLC diagnosis
• Patient had ≥ 1 measurable intracranial lesion after initial diagnosis of BM
• Patient was treated with capmatinib after diagnosis of BM (any line)

Exclusion Criteria

• Patients 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 mutations
• Patients with other known actionable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to receive alternative targeted therapies
• Patients who had been treated with METis in any therapy line before or after the study index date
• Patients who had participated in a clinical trial related to treatment for NSCLC at any time before or after the study index date

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asymptomatic Brain Metastases; Patients with Asymptomatic Brain Metastases	Drug: Capmatinib; Patients receiving Capmatinib
Symptomatic Brain Metastases; Patient with Symptomatic Brain Metastases	Drug: Capmatinib; Patients receiving Capmatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	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.	Up to approximately 23 months
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)	rwDCR was assessed per the pseudo-RECIST version 1.1 or as assessed by an HCP, as available.	Up to approximately 23 months
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	CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions.	Up to approximately 33 months
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: December 29, 2022
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: CINC280AUS13