NCT04317651

Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Fondazione Ricerca Traslazionale · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, observational, retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in ALK positive NSCLC treated in real life setting.

Detailed description

Primary efficacy objective: To assess the efficacy of crizotinib in real life setting Secondary objectives: 1. To evaluate the therapeutic response to crizotinib-based treatment 2. To identify additional biomarkers selectively present in the ALK positive population 3. To assess the safety of crizotinib (250 mg/bid) in the treatment of NSCLC in real life setting Non-small-cell Lung Cancer (NSCLC) remains the leading cause of cancer death in Western Countries. Identification of anaplastic lymphoma kinase (ALK) gene rearrangements reinforced the role of targeted therapies in lung cancer. The EML4-ALK fusion gene is detected in 3-7% of patients with adenocarcinomas of the lung and is associated with specific clinical pathological features, including young age, absent or minimal smoking history and adenocarcinoma histology. However, such clinical features do not properly select patients for ALK inhibitors (ALK-Is) and, consequently, molecular testing is mandatory. Indeed, current guidelines recommend to test ALK rearrangements at diagnosis all patients with advanced lung adenocarcinoma, due to immediate therapeutic implications.

Conditions

• Non Small Cell Lung Cancer
• Advanced Cancer
• Metastatic Cancer

Timeline

• Start date: 2019-05-16
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2020-03-23
• Last updated: 2020-03-25

Locations

23 sites across 1 country: Italy