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OpenTrials
Completed

NCT Number: NCT05675683

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

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.

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Key information

Conditions

Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

18 Novartis Investigative Sites in the US

East Hanover, New Jersey, 07936-1080, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capmatinib

Drug

Patients receiving Capmatinib

Primary outcomes

  1. Time-to-treatment discontinuation (TTD) from treatment initiation until discontinuation of capmatinib line of therapy or death, whichever was earlier

    Time frame: Up to 12 months

Secondary outcomes

  1. 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

    Time frame: Up to approximately 23 months

    rwORR was assessed per the pseudo-Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or as assessed by a healthcare professional (HCP), as available. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions. Best overall response consisted of CR+PR.

  2. 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)

    Time frame: Up to approximately 23 months

    rwDCR was assessed per the pseudo-RECIST version 1.1 or as assessed by an HCP, as available.

  3. 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

    Time frame: Up to approximately 33 months

    CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions.

  4. Real-world progression-free survival (rwPFS): Time from start of capmatinib therapy until the earliest of a clinically documented systemic disease progression

    Time frame: Up to 12 months

  5. Overall survival (OS): Time from start of capmatinib therapy until death

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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