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

NCT ID: NCT05675683

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2021-12-31

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.

Conditions

Metastatic Non-Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Asymptomatic Brain Metastases

Patients with Asymptomatic Brain Metastases

Capmatinib

Intervention Type: DRUG

Patients receiving Capmatinib

Symptomatic Brain Metastases

Patient with Symptomatic Brain Metastases

Capmatinib

Intervention Type: DRUG

Patients receiving Capmatinib

Interventions

Capmatinib

Patients receiving Capmatinib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

18 Novartis Investigative Sites in the US

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CINC280AUS13

Identifier Type: -

Identifier Source: org_study_id