Clinical trial NCT06161051: Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
Official title: Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation
Keywords: aNSCLC
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 287
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 advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Data abstraction was performed by the participating physician.


Eligibility criteria: Inclusion Criteria:

* Patient was aged ≥ 18 years at the time of NSCLC diagnosis.
* Had histologically confirmed advanced (stage IIIB, IIIC, or IV) NSCLC with MET exon 14 skipping mutation.
* Initiated first-line (1L) treatment for aNSCLC between 1 January 2017 and date of data abstraction with one of the following treatment regimen:

  * Capmatinib
  * IO agent in monotherapy (e.g., atezolizumab, pembrolizumab)
  * CT regimen, single agent or combinations of CT agents (e.g., platinum agents, taxane agents, gemcitabine, pemetrexed)
  * Combination regimen containing IO and CT agents
* Had ≥ 6 months of potential follow-up time after the initiation of 1L treatment for aNSCLC, except if the patient died sooner.
* Living or deceased at the time of chart abstraction.

Exclusion Criteria:

* Presence of other mutations (e.g., EGFR, ALK, ROS1, RET, NTRK, BRAF, or KRAS) at any time.
* Treatment with other MET inhibitors such as crizotinib or tepotinib at any time during the study period.
* Participation in clinical trials related to treatment for NSCLC at any timepoint.

Primary outcomes:
measure: Time-to-treatment discontinuation (TTD)
timeFrame: Up to approximately 5 years
measure: Real-world overall response rate (rwORR)
timeFrame: Up to approximately 5 years
measure: Real-world disease control rate (rwDCR)
timeFrame: Up to approximately 5 years
measure: Real-world duration of response (rwDOR)
timeFrame: Up to approximately 5 years
measure: Real-world progression-free survival (rwPFS)
timeFrame: Up to approximately 5 years
measure: Overall survival (OS)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Number of patients per demographic category
timeFrame: Baseline
measure: Mean age
timeFrame: Baseline
measure: Number of patients per clinical characteristic category
timeFrame: Baseline
measure: Number of patients per comorbidity
timeFrame: Up to 6 months pre-baseline
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: