Clinical trial NCT05675683: Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
Official title: Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Non-Small Cell Lung Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


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

Primary outcomes:
measure: Time-to-treatment discontinuation (TTD) from treatment initiation until discontinuation of capmatinib line of therapy or death, whichever was earlier
timeFrame: Up to 12 months
Secondary outcomes:
measure: 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
timeFrame: Up to approximately 23 months
measure: 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)
timeFrame: Up to approximately 23 months
measure: 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
timeFrame: Up to approximately 33 months
measure: Real-world progression-free survival (rwPFS): Time from start of capmatinib therapy until the earliest of a clinically documented systemic disease progression
timeFrame: Up to 12 months
measure: Overall survival (OS): Time from start of capmatinib therapy until death
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: 18 Novartis Investigative Sites in the US
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: