Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States

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.

Study Overview

• Status: Completed
• Conditions: Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation

• Study Type: Observational
• Enrollment (Actual): 287

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Capmatinib
IO monotherapy
Chemotherapy alone
IO + chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-treatment discontinuation (TTD)		Up to approximately 5 years
Real-world overall response rate (rwORR)	Proportion of patients with best overall response of either a complete response (CR) or partial response (PR) to the line of therapy based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or per healthcare professional (HCP) assessment.	Up to approximately 5 years
Real-world disease control rate (rwDCR)	Proportion of patients with best overall response of either a CR+PR or stable disease to the line of therapy based on RECIST version 1.1, or per HCP assessment.	Up to approximately 5 years
Real-world duration of response (rwDOR)	Time from the date of first documented CR or PR to the first documented systemic disease progression or death due to any cause.	Up to approximately 5 years
Real-world progression-free survival (rwPFS)	Time from start of therapy until the earliest of a clinically documented systemic disease progression.	Up to approximately 5 years
Overall survival (OS)	Time from start of therapy until death.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean age		Baseline
Number of patients per demographic category	Demographic categories included sex, race/ethnicity, and insurance status.	Baseline
Number of patients per clinical characteristic category	Clinical characteristics included staging, presence and site(s) of metastases, number of lesions, and performance status.	Baseline
Number of patients per comorbidity		Up to 6 months pre-baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: aNSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CINC280AUS16