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

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Novartis

Status

Completed

Conditions

Metastatic Non-Small Cell Lung Cancer

Treatments

Drug: Capmatinib

Study type

Observational

Funder types

Industry

Identifiers

NCT05675683
CINC280AUS13

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

68 participants in 2 patient groups

Asymptomatic Brain Metastases
Description:
Patients with Asymptomatic Brain Metastases
Treatment:
Drug: Capmatinib
Symptomatic Brain Metastases
Description:
Patient with Symptomatic Brain Metastases
Treatment:
Drug: Capmatinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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