Status:
WITHDRAWN
A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-small Cell Lung Carcinoma (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to establish the intracranial efficacy of single agent capmatinib in the population of treatment-naïve or pretreated with one or two prior lines of systemic therapies for ...
Detailed Description
This is a prospectively designed, multicenter, open-label, two-cohort, phase II study to evaluate the intracranial efficacy of single agent capmatinib in participants with MET exon 14 mutated NSCLC an...
Eligibility Criteria
Inclusion
- Histologically confirmed stage IV (according to Version 8 of the American Joint Committee on Cancer (AJCC)) NSCLC that is EGFR wt, ALK rearrangement negative as assessed by a validated test as part of the participant's standard of care and has MET∆ex14 mutation per Novartis-designated central laboratory or (US only) locally with FoundationOne Companion Diagnostic (F1CDx) .
- Treatment naïve or up to two prior lines of systemic therapy for stage IIIb-IV NSCLC
- Measurable intracranial lesions:
- Cohort 1 and Cohort 2 (without leptomeningeal carcinoma): At least 1 measurable intracranial lesion per RANO-BM criteria, documented by a radiologist/neuroradiologist (treated or untreated).
- Cohort 2 (with leptomeningeal carcinoma): participants with leptomeningeal carcinoma may not have measurable lesions. In this circumstance, the participant's disease will be considered to have non-target lesions only at baseline and their response based on descriptive clinical criteria by physician assessment.
- Capable of undergoing magnetic resonance imaging (MRI)
- ECOG performance status of 0 or 1
Exclusion
- Only for Cohort 1: any neurological symptoms related to brain metastases
- For participants in Cohort 2 with prior brain therapy: Treatment with stereotactic radiosurgery within 14 days prior to the start of study treatment or treatment with WBRT within 14 days prior to the start of study treatment
- Prior treatment with any MET targeting therapy or HGF inhibitor
- Participants with other known druggable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to alternative targeted therapies as applicable per local regulations and treatment guidelines
- Presence or history of ILD or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
- Clinically significant, uncontrolled heart diseases including History of familial long QT syndrome, sudden death or congenital long QT syndrome
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04460729
Start Date
November 11 2020
End Date
November 17 2023
Last Update
December 3 2020
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