NCT02727335

Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 318 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Detailed description

Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program. This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.

Conditions

• Non-small Cell Lung Cancer
• Anaplastic Lymphoma Kinase Gene Mutation

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-04-04
• Last updated: 2023-05-24

Locations

63 sites across 1 country: France