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

  • participants needed
  • sponsor
    Fondazione Ricerca Traslazionale
Updated on 10 August 2022
lung cancer
stage iv non-small cell lung cancer
lung carcinoma


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.


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.

Condition Non Small Cell Lung Cancer, Advanced Cancer, Metastatic Cancer
Clinical Study IdentifierNCT04317651
SponsorFondazione Ricerca Traslazionale
Last Modified on10 August 2022

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