RW Effectiveness of Capmatinib in Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)

NCT05154344 | Completed

• 1 other identifier: IFCT-2104
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

MET Alterations; Non Small Cell Lung Cancer; METex14 Mutations

Keywords

Expanded access program; Capmatinib; MET TKIs; IFCT

Outcome Measures

Primary Outcomes (1)

• time to treatment failure

  time to treatment failure in patients with advanced NSCLC harboring a METex14 mutation receiving capmatinib as part of the French compassionate use program (ATU)

  2 years

Interventions

Capmatinib DRUG

Available through expanded access

Also known as: Tabrecta

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

Patients with advanced NSCLC harboring a METex14 mutation receiving capmatinib as part of the French compassionate use program (ATU).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead
• Novartis: collaborator

Study Sites (2)

CHU

Lille, France

Location

CHU

Tours, France

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 Design

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

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 13, 2021
• Study Start: November 29, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

FR (2)