Etude : IFCT-2104 / CapmATU

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : IFCT-2104 / CapmATU

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH3

Dernière MÀJ : 20/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Cohorte de patients porteurs d’un cancer bronchique non à petites cellules avec une altération de MET et traité par capmatinib (ATU)

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Informations complémentaires
Schéma : 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.
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.

Phase : NA

Stade : Localement avancé à Métastatique

1, 2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification) at time of capmatinib initiation
- Presence of a MET dysregulation diagnosed on tumor sample and/or on liquid biopsy
- Patients who were informed about the study and accepted for their data to be collected.
-Patients who received at least one dose of treatment with capmatinib as part of the compassionate use program (ATU), whatever the line of treatment.
- Selection period spans from June 1st 2019 (date of start of French ATU) until August 31st 2021 for first dose of capmatinib.
- Age >18 y

Critères de non-inclusion : - Patients enrolled in a clinical trial assessing treatment with capmatinib. (ATU was granted to patients unable to meet eligibility criteria for on-going recruiting trials, unable to participate to other clinical trials, or because other medical interventions were not considered appropriate or acceptable).
- Patients who were included in the French Early Access Program (ATU program) but did not receive any capmatinib treatment.
- Patients who have expressed explicit refusal to collect his or her data
- Patients with a psychiatric history that hinders the comprehension of the information leaflet
- Patients under curatorship or guardianship
- Unability to obtain data collection
Informations relatives au promoteur
Promoteur :
Type de sponsor : Institutionnel
75009 PARIS 09

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CH Jacques Monod Flers - Rue Eugène Garnier - 61100 FLERS

Investigateur :

Henintsoa MACE

Statut de l'essai : OUVERT

MAJ : 20/12/2021