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

March 24, 2020 updated by: Fondazione Ricerca Traslazionale
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Avellino, Italy, 83100
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"
        • Contact:
        • Principal Investigator:
          • Cesare Gridelli, MD
      • Bari, Italy, 70124
        • Recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II
        • Principal Investigator:
          • Domenico Galetta, MD
        • Contact:
        • Contact:
      • Firenze, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Principal Investigator:
          • Francesca Mazzoni, MD
        • Contact:
      • Messina, Italy, 98158
        • Recruiting
        • AO Papardo
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Contact:
        • Principal Investigator:
          • Gianluca Spitalieri, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
        • Principal Investigator:
          • Alessandro Morabito, MD
        • Contact:
      • Napoli, Italy, 80131
        • Recruiting
        • A.O.R.N dei Colli - Ospedale Monaldi
        • Contact:
        • Principal Investigator:
          • Francovito Piantedosi, MD
      • Olbia, Italy, 07026
        • Not yet recruiting
        • Ospedale Giovanni Paolo II ASL-2 Olbia
        • Contact:
        • Principal Investigator:
          • Claudio Sini, MD
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Principal Investigator:
          • Laura Bonanno, MD
        • Contact:
        • Sub-Investigator:
          • Alessandro Del Maso, MD
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliera-Universitaria di Parma
        • Contact:
          • Marcello Tiseo, MD
          • Phone Number: 0521702316-702682
          • Email: mtiseo@ao.pr.it
      • Perugia, Italy, 06132
        • Not yet recruiting
        • Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia
        • Principal Investigator:
          • Fausto Roila, MD
        • Contact:
      • Ravenna, Italy, 48121
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • IRCCS- Arcispedale Santa Maria Nuova
        • Principal Investigator:
          • Maria Pagano, MD
        • Contact:
      • Roma, Italy, 00128
        • Recruiting
        • Policlinico Universitario "Campus Biomedico" di Roma
        • Contact:
        • Principal Investigator:
          • Giuseppe Tiseo, MD
      • Roma, Italy, 00152
        • Recruiting
        • Azienda Ospedaliera San Camillo-Forlanini
        • Contact:
        • Principal Investigator:
          • Maria Rita Migliorino, MD
      • Varese, Italy, 21100
        • Recruiting
        • ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi"
        • Principal Investigator:
          • Alessandro Tuzi, MD
        • Contact:
      • Verona, Italy, 37134
        • Not yet recruiting
        • Policlinico 'G.B.Rossi' Borgo Roma - Azienda Ospedaliera Universitaria Integrata (Giampaolo Tortora)
        • Contact:
        • Principal Investigator:
          • Antonio Santo
    • Lucca
    • Milano
      • Monza, Milano, Italy, 20900
        • Recruiting
        • A.O. San Gerardo
        • Contact:
        • Principal Investigator:
          • Diego Luigi Cortinovis, MD
    • Potenza
      • Rionero In Vulture, Potenza, Italy, 85028
        • Not yet recruiting
        • Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata
        • Principal Investigator:
          • Michele Aieta, MD
        • Contact:
    • Ravenna
      • Meldola, Ravenna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
        • Contact:
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Recruiting
        • A.O.U. San Luigi Gonzaga
        • Contact:
    • Verona
      • Negrar, Verona, Italy, 37024
        • Not yet recruiting
        • Sacro Cuore- Don Calabria Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sistematic review of medical records
Time Frame: Six months

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
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Objectives
Time Frame: Six months
  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
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Ricerca Traslazionale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECIALK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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