Clinical trial NCT04317651: Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
Official title: Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Advanced Cancer
Metastatic Cancer
Keywords: crizotinib
Non Small Cell Lung Cancer
Metastatic Cancer
Advanced Cancer
NSCLC
ALK positive
Lead sponsor: Fondazione Ricerca Traslazionale
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with crizotinib at the standard doses of 250 mg/bid. Based on the total number of patients treated with Crizotinib in the NPU program (approximately 900) as well as on the clinical experience, the investigators expect that almost 500 patients will enter this study and that tumor biopsies will be available on approximately 100 patients.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sistematic review of medical records
timeFrame: Six months
Secondary outcomes:
measure: Secondary Objectives
timeFrame: Six months
Other outcomes:
Locations:
city: Camaiore
country: Italy
facility: Ospedale Versilia
state: Lucca
city: Monza
country: Italy
facility: A.O. San Gerardo
state: Milano
city: Rionero In Vulture
country: Italy
facility: Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata
state: Potenza
city: Meldola
country: Italy
facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: Ravenna
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga
state: Torino
city: Negrar
country: Italy
facility: Sacro Cuore- Don Calabria Hospital
state: Verona
city: Avellino
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Messina
country: Italy
facility: AO Papardo
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: A.O.R.N dei Colli - Ospedale Monaldi
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
city: Olbia
country: Italy
facility: Ospedale Giovanni Paolo II ASL-2 Olbia
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Parma
country: Italy
facility: Azienda Ospedaliera-Universitaria di Parma
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia
city: Ravenna
country: Italy
facility: Ospedale di Ravenna
city: Reggio Emilia
country: Italy
facility: IRCCS- Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Policlinico Universitario "Campus Biomedico" di Roma
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo-Forlanini
city: Varese
country: Italy
facility: ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi"
city: Verona
country: Italy
facility: Policlinico 'G.B.Rossi' Borgo Roma - Azienda Ospedaliera Universitaria Integrata (Giampaolo Tortora)
Study officials:
References: