Crizotinib in ALK Rearranged Non-small-cell Lung Cancer (SPECIALK)

Fondazione Ricerca Traslazionale

Status: Unknown

Conditions: Metastatic Cancer; Advanced Cancer; Non Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04317651

SPECIALK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC
• 2. Former participation in the Italian NPU program between December 2010 - April 2013 or receiving crizotinib according to 648 legislative Decrete from April 2013 to February 2015 and thereafter in clinical practice up to December 31st, 2017.
• 3. Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician
• 4. ALK rearrangement report including details of method and cutoff used for ALK testing
• 5. Data on prior therapies
• 6. Data on toxicity
• 7. Data on crizotinib therapy efficacy including response to the therapy and survival
• 8. Data on site of metastases
• 9. Availability of archival tissue (not mandatory)
• 10. Signed Informed Consent for alive and contactable patients

Exclusion criteria

• 1. Lack of clinical data
• 2. No evidence of ALK rearrangemement
• 3. Early death defined as fatal outcome within 30 days since the first crizotinib dose
• 4. Absence of any radiological assessment
• 5. No data on crizotinib efficacy including survival