Status:
UNKNOWN
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
Lead Sponsor:
Fondazione Ricerca Traslazionale
Conditions:
Non Small Cell Lung Cancer
Advanced Cancer
Eligibility:
All Genders
18+ years
Brief 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 addi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04317651
Start Date
May 16 2019
End Date
June 1 2022
Last Update
March 25 2020
Active Locations (23)
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1
Ospedale Versilia
Camaiore, Lucca, Italy, 55041
2
A.O. San Gerardo
Monza, Milano, Italy, 20900
3
Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Potenza, Italy, 85028
4
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Ravenna, Italy, 47014