AzTrials
AzTrials

Non Small Cell Lung CancerSPECIALKNCT04317651

Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

An observational study of Non Small Cell Lung Cancer and Advanced Cancer, run by Fondazione Ricerca Traslazionale at 23 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
500 participants
Where
23 sitesItaly
Study dates
16 May 2019to Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country.

Federico Cappuzzo, MD contact

089301545

f.cappuzzo@gmail.com

Lorenza Landi, MD contact

089301545

landi.lorenza@gmail.com

23 sites in 1 country

Italy23 sites, 23 recruiting

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

    Avellino, 83100

    Cesare Gridelli, MD, 0825 203945 - 203573, cgridelli@libero.it

    Cesare Gridelli, MD

    Recruiting

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

    Domenico Galetta, MD, 0805555418, galetta@teseo.it

    Sandro Cassiano, Ph, sandrocassiano@libero.it

    Recruiting

  • Ospedale Versilia

    Camaiore, Lucca, 55041

    Andrea Camerini, MD, andrea.camerini@uslnordovest.toscana.it

    Andrea Camerini, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

    Francesca Mazzoni, MD, francescamazzoni@hotmail.com

    Francesca Mazzoni, MD

    Recruiting

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

    Meldola, Ravenna, 47014

    Angelo Delmonte, MD, 0543 739100, angelo.delmonte@irst.emr.it

    Angelo Delmonte, MD

    Recruiting

  • AO Papardo

    Messina, 98158

    Vincenzo Adamo, MD, +390903996150, vadamo@unime.it

    Vincenzo Adamo, MD

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Gianluca Spitalieri, MD, +39 02 94372730, gianluca.spitaleri@ieo.it

    Gianluca Spitalieri, MD

    Recruiting

  • A.O. San Gerardo

    Monza, Milano, 20900

    Diego Luigi Cortinovis, MD, d.cortinovis@asst-monza.it

    Diego Luigi Cortinovis, MD

    Recruiting

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

    Naples, 80131

    Francovito Piantedosi, MD, 0817064086/65213, fvpiantedosi1@tin.it

    Francovito Piantedosi, MD

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

    Alessandro Morabito, MD, 081-5903631, a.morabito@istitutotumori.na.it

    Alessandro Morabito, MD

    Recruiting

  • Sacro Cuore- Don Calabria Hospital

    Negrar, Verona, 37024

    Stefania Gori, MD, 0456013472, stefania.gori@sacrocuore.it

    Stefania Gori, MD

    Not yet recruiting

  • Ospedale Giovanni Paolo II ASL-2 Olbia

    Olbia, 07026

    Claudio Sini, audiosini@tiscali.it

    Claudio Sini, MD

    Not yet recruiting

  • A.O.U. San Luigi Gonzaga

    Orbassano, Torino, 10043

    Silvia Novello, MD, 0119026978, silvia.novello@unito.it

    Silvia Novello, MD

    Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

    Laura Bonanno, MD, laura.bonanno@iov.veneto.it

    Laura Bonanno, MD

    Recruiting

  • Azienda Ospedaliera-Universitaria di Parma

    Parma, 43126

    Marcello Tiseo, MD, 0521702316-702682, mtiseo@ao.pr.it

    Marcello Tiseo, MD

    Recruiting

  • Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia

    Perugia, 06132

    Fausto Roila, MD, roila.fausto@libero.it

    Fausto Roila, MD

    Not yet recruiting

  • Ospedale di Ravenna

    Ravenna, 48121

    Lorenza Landi, MD, landi.lorenza@gmail.com

    Michela Spreafico, Biologist, 0544286223, michela.spreafico@irst.emr.it

    Recruiting

  • IRCCS- Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

    Maria Pagano, MD, Maria.Pagano@ausl.re.it

    Maria Pagano, MD

    Recruiting

  • Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata

    Rionero in Vulture, Potenza, 85028

    Michele Aieta, MD, michele.aieta@crob.it

    Michele Aieta, MD

    Not yet recruiting

  • Policlinico Universitario "Campus Biomedico" di Roma

    Roma, 00128

    Giuseppe Tiseo, MD, g.tonini@unicampus.it

    Giuseppe Tiseo, MD

    Recruiting

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152

    Maria Rita Migliorino, MD, 0658704670, mmigliorino@scamilloforlanini.rm.it

    Maria Rita Migliorino, MD

    Recruiting

  • ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi"

    Varese, 21100

    Alessandro Tuzi, MD, alessandro.tuzi@asst-settelaghi.it

    Alessandro Tuzi, MD

    Recruiting

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

    Verona, 37134

    Antonio Santo, MD, antonio.santo@aovr.veneto.it

    Antonio Santo

    Not yet recruiting

Other trials in Italy

About this study

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.

Read the 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.

Keywords
crizotinib, Non Small Cell Lung Cancer, Metastatic Cancer, Advanced Cancer, NSCLC, ALK positive
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sistematic review of medical records

    To assess the overall efficacy of crizotinib (250 mg/bid) in terms of Response rate, Progression-Free Survival and Overall Survival in the treatment of NSCLC in real life setting. Median PFS, as reported by a recent metanalysis, is 9.4 months (first and second line together) corresponding to a 12 months PFS rate of about 40%. The analysis of 500 patients will allow to estimate the median PFS with a semi-width 95% confidence interval of 1.2 months. OS will be calculated from the first day of treatment until the date of death from any cause. Any patient not known to have died at the time of data analysis will be censored at the time of the last recorded date on which the patient was known to be alive. Time to events will be summarized using Kaplan-Meier estimation.

    ORR, defined as the proportion of patients with a best overall response of either Complete response or Partial response, will be calculated based on disease status evaluated by the investigator according to RECIST v1.1

    Measured: Six months

Secondary outcomes (1)

  1. Secondary Objectives

    1. To define clinical and biological characteristics of patients not responding to crizotinib therapy at the first tumor assessment versus individuals with complete or deep partial response (> 50% reduction in the sum of target lesions)
    2. To define additional biomarkers selectively present in the ALK positive population
    3. To explore outcome of individuals with brain metastases
    4. To define timing of local ablative therapy in presence of brain metastas

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start16 May 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317651
Sponsor's protocol ID
SPECIALK
Acronym
SPECIALK
Status last verified
Mar 2020
First submitted
19 Mar 2020
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer and Advanced Cancer, run by Fondazione Ricerca Traslazionale at 23 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Federico Cappuzzo, MD (089301545, f.cappuzzo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sistematic review of medical records (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in