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

NCT05675683 | Completed

• 1 other identifier: CINC280AUS13
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  Up to 12 months

Secondary Outcomes (5)

• 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

  Up to approximately 23 months

• 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)

  Up to approximately 23 months

• 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

  Up to approximately 33 months

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

  Up to 12 months

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

  Up to 12 months

Study Arms (2)

Asymptomatic Brain Metastases

Patients with Asymptomatic Brain Metastases

Drug: Capmatinib

Symptomatic Brain Metastases

Patient with Symptomatic Brain Metastases

Drug: Capmatinib

Interventions

Capmatinib DRUG

Patients receiving Capmatinib

Asymptomatic Brain Metastases; Symptomatic Brain Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

18 Novartis Investigative Sites in the US

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

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: October 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 9, 2023

Record last verified: 2022-12

Locations

US (1)