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Crizotinib in ALK Rearranged ...

Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-16

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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

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Non Small Cell Lung Cancer Advanced Cancer Metastatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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Italy

Central Contacts

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Federico Cappuzzo, MD

Role: CONTACT

[email protected]

089301545

Lorenza Landi, MD

Role: CONTACT

[email protected]

089301545

Facility Contacts

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Andrea Camerini, MD

Role: primary

[email protected]

Diego Luigi Cortinovis, MD

Role: primary

[email protected]

Role: backup

[email protected]

Role: primary

[email protected]

Antonio Santo, MD

Role: primary

[email protected]

Other Identifiers

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SPECIALK

Identifier Type: -

Identifier Source: org_study_id

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Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation

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Detailed Description

Conditions

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fondazione Ricerca Traslazionale

Responsible Party

Locations

Ospedale Versilia

A.O. San Gerardo

Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata

IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

A.O.U. San Luigi Gonzaga

Sacro Cuore- Don Calabria Hospital

Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"

IRCCS Istituto Tumori Giovanni Paolo II

Azienda Ospedaliero-Universitaria Careggi

AO Papardo

Istituto Europeo di Oncologia

A.O.R.N dei Colli - Ospedale Monaldi

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Ospedale Giovanni Paolo II ASL-2 Olbia

Istituto Oncologico Veneto IRCCS

Azienda Ospedaliera-Universitaria di Parma

Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia

Ospedale di Ravenna

IRCCS- Arcispedale Santa Maria Nuova

Policlinico Universitario "Campus Biomedico" di Roma

Azienda Ospedaliera San Camillo-Forlanini

ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi"

Policlinico 'G.B.Rossi' Borgo Roma - Azienda Ospedaliera Universitaria Integrata (Giampaolo Tortora)

Countries

Central Contacts

Federico Cappuzzo, MD

Lorenza Landi, MD

Facility Contacts

Andrea Camerini, MD

Diego Luigi Cortinovis, MD

Michele Aieta, MD

Angelo Delmonte, MD

Silvia Novello, MD

Stefania Gori, MD

Cesare Gridelli, MD

Domenico Galetta, MD

Sandro Cassiano, Ph

Francesca Mazzoni, MD

Vincenzo Adamo, MD

Gianluca Spitalieri, MD

Francovito Piantedosi, MD

Alessandro Morabito, MD

Claudio Sini

Laura Bonanno, MD

Marcello Tiseo, MD

Fausto Roila, MD

Lorenza Landi, MD

Michela Spreafico, Biologist

Maria Pagano, MD

Giuseppe Tiseo, MD

Maria Rita Migliorino, MD

Alessandro Tuzi, MD

Antonio Santo, MD

Other Identifiers

SPECIALK

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