Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— SPECIALK  

Official title:

Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317651
• Other study ID #: SPECIALK
• Status: Recruiting
• Start date: May 16, 2019
• Est. completion date: June 2022

Study information

• Verified date: March 2020
• Source: Fondazione Ricerca Traslazionale
• Contact: Federico Cappuzzo, MD
• Phone: 089301545
• Email: f.cappuzzo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Non Small Cell Lung Cancer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Ricerca Traslazionale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Objectives	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); To define additional biomarkers selectively present in the ALK positive population; To explore outcome of individuals with brain metastases; To define timing of local ablative therapy in presence of brain metastas	Six months