Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
SPECIALK
1 other identifier
observational
500
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2019
CompletedFirst Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMarch 25, 2020
March 1, 2020
2.5 years
March 19, 2020
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Six months
Secondary Outcomes (1)
Secondary Objectives
Six months
Eligibility Criteria
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.
You may qualify if:
- \. Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC
- \. 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.
- \. Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician
- \. ALK rearrangement report including details of method and cutoff used for ALK testing
- \. Data on prior therapies
- \. Data on toxicity
- \. Data on crizotinib therapy efficacy including response to the therapy and survival
- \. Data on site of metastases
- \. Availability of archival tissue (not mandatory)
- \. Signed Informed Consent for alive and contactable patients
You may not qualify if:
- \. Lack of clinical data
- \. No evidence of ALK rearrangemement
- \. Early death defined as fatal outcome within 30 days since the first crizotinib dose
- \. Absence of any radiological assessment
- \. No data on crizotinib efficacy including survival
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Ospedale Versilia
Camaiore, Lucca, 55041, Italy
A.O. San Gerardo
Monza, Milano, 20900, Italy
Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Potenza, 85028, Italy
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Ravenna, 47014, Italy
A.O.U. San Luigi Gonzaga
Orbassano, Torino, 10043, Italy
Sacro Cuore- Don Calabria Hospital
Negrar, Verona, 37024, Italy
Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"
Avellino, 83100, Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
AO Papardo
Messina, 98158, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
A.O.R.N dei Colli - Ospedale Monaldi
Napoli, 80131, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, 80131, Italy
Ospedale Giovanni Paolo II ASL-2 Olbia
Olbia, 07026, Italy
Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Azienda Ospedaliera-Universitaria di Parma
Parma, 43126, Italy
Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia
Perugia, 06132, Italy
Ospedale di Ravenna
Ravenna, 48121, Italy
IRCCS- Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
Policlinico Universitario "Campus Biomedico" di Roma
Roma, 00128, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00152, Italy
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi"
Varese, 21100, Italy
Policlinico 'G.B.Rossi' Borgo Roma - Azienda Ospedaliera Universitaria Integrata (Giampaolo Tortora)
Verona, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2020
First Posted
March 23, 2020
Study Start
May 16, 2019
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
March 25, 2020
Record last verified: 2020-03