Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05154344 |
Other study ID # |
IFCT-2104 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 29, 2021 |
Est. completion date |
February 1, 2022 |
Study information
Verified date |
January 2023 |
Source |
Intergroupe Francophone de Cancerologie Thoracique |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
CapmATU study will evaluate time to treatment failure, progression-free survival, overall
survival, best response and safety in patients with advanced MET-dysregulated non-small cell
lung cancer who received capmatinib as part of an expanded access program. Those outcomes
will be correlated to clinical, pathological, and radiological characteristics of patients.
Description:
Capmatinib has been approved in the USA and Japan. In France, a compassionate use for
capmatinib has been approved in June 2019 for patients with MET alterations, including
METex14 mutations and MET amplification. In March 2021, 204 patients are or have been treated
with compassionate use capmatinib as part of this program, most of them (n=175) harboring a
METex14 mutation.
So far, data on activity and safety of new-generation MET TKIs are still sparse and only
based on prospective clinical studies. The CapmATU study is a unique opportunity to describe
patients' characteristics and outcomes, and confirm effectiveness of capmatinib in a large
cohort of METex14 NSCLC. Moreover, it will provide original real-world evidence (RWE). RWE
can be used in oncology to further characterize the safety and efficacy of drugs in the
post-marketing setting. This may include confirmation of clinical benefit for regulatory
purposes, expansion of labeling claims to new indications, testing of alternate doses and
schedules of drugs, and assessment of drug activity in biomarker-defined subgroups and other
special populations. This may be even more important in the context of METex14 NSCLC patients
since no real world data with new generation MET TKIs have been reported so far. Indeed, this
study will allow to determine whether the antitumor activity of capmatinib reported in the
GEOMETRY-MONO-1 study can be observed in less selected patients. Given the older age and
associated comorbidities of METex14 NSCLC patients, most of them may not be eligible to a
clinical trial, thus emphasizing the need for real-world evidence. Finally, the biological
part of this study (CapmATU-BIO) will offer opportunity to identify biomarkers of sensitivity
or acquired resistance to capmatinib, which is a poorly explored field of research so far.
In this context, the objectives of this non-interventional retrospective French
population-base study are to describe the characteristics of patients with MET-dysregulated
NSCLC, assess effectiveness and safety of capmatinib in these patients and identify
biomarkers of benefit from capmatinib.