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

Metastatic Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675683
• Other study ID #: CINC280AUS13
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Metastatic Non-Small Cell Lung Cancer

Intervention

Drug:
• Capmatinib
Patients receiving Capmatinib

Locations

Country	Name	City	State
United States	18 Novartis Investigative Sites in the US	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival (OS): Time from start of capmatinib therapy until death		Up to 12 months