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

NCT ID: NCT06161051

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2022-12-07

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation

Keywords

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aNSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Capmatinib

No interventions assigned to this group

IO monotherapy

No interventions assigned to this group

Chemotherapy alone

No interventions assigned to this group

IO + chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CINC280AUS16

Identifier Type: -

Identifier Source: org_study_id