Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-02 @ 5:20 PM
Study NCT ID:
NCT04317651
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sistematic review of medical records', 'timeFrame': 'Six months', 'description': '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.\n\nORR, 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'}], 'secondaryOutcomes': [{'measure': 'Secondary Objectives', 'timeFrame': 'Six months', 'description': '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)\n2. To define additional biomarkers selectively present in the ALK positive population\n3. To explore outcome of individuals with brain metastases\n4. To define timing of local ablative therapy in presence of brain metastas'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['crizotinib', 'Non Small Cell Lung Cancer', 'Metastatic Cancer', 'Advanced Cancer', 'NSCLC', 'ALK positive'], 'conditions': ['Non Small Cell Lung Cancer', 'Advanced Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Primary efficacy objective:\n\nTo assess the efficacy of crizotinib in real life setting\n\nSecondary objectives:\n\n1. To evaluate the therapeutic response to crizotinib-based treatment\n2. To identify additional biomarkers selectively present in the ALK positive population\n3. To assess the safety of crizotinib (250 mg/bid) in the treatment of NSCLC in real life setting\n\nNon-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC\n* 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.\n* 3\\. Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician\n* 4\\. ALK rearrangement report including details of method and cutoff used for ALK testing\n* 5\\. Data on prior therapies\n* 6\\. Data on toxicity\n* 7\\. Data on crizotinib therapy efficacy including response to the therapy and survival\n* 8\\. Data on site of metastases\n* 9\\. Availability of archival tissue (not mandatory)\n* 10\\. Signed Informed Consent for alive and contactable patients\n\nExclusion Criteria:\n\n* 1\\. Lack of clinical data\n* 2\\. No evidence of ALK rearrangemement\n* 3\\. Early death defined as fatal outcome within 30 days since the first crizotinib dose\n* 4\\. Absence of any radiological assessment\n* 5\\. No data on crizotinib efficacy including survival'}, 'identificationModule': {'nctId': 'NCT04317651', 'acronym': 'SPECIALK', 'briefTitle': 'Crizotinib in ALK Rearranged Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Ricerca Traslazionale'}, 'officialTitle': 'Crizotinib in ALK Rearranged Non-small-cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SPECIALK'}}, 'contactsLocationsModule': {'locations': [{'zip': '55041', 'city': 'Camaiore', 'state': 'Lucca', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Camerini, MD', 'role': 'CONTACT', 'email': 'andrea.camerini@uslnordovest.toscana.it'}, {'name': 'Andrea Camerini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Versilia', 'geoPoint': {'lat': 43.94265, 'lon': 10.29754}}, {'zip': '20900', 'city': 'Monza', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Diego Luigi Cortinovis, MD', 'role': 'CONTACT', 'email': 'd.cortinovis@asst-monza.it'}, {'name': 'Diego Luigi Cortinovis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'Potenza', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Aieta, MD', 'role': 'CONTACT', 'email': 'michele.aieta@crob.it'}, {'name': 'Michele Aieta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '47014', 'city': 'Meldola', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Delmonte, MD', 'role': 'CONTACT', 'email': 'angelo.delmonte@irst.emr.it', 'phone': '0543 739100'}, {'name': 'Angelo Delmonte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '10043', 'city': 'Orbassano', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Novello, MD', 'role': 'CONTACT', 'email': 'silvia.novello@unito.it', 'phone': '0119026978'}, {'name': 'Silvia Novello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefania Gori, MD', 'role': 'CONTACT', 'email': 'stefania.gori@sacrocuore.it', 'phone': '0456013472'}, {'name': 'Stefania Gori, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sacro Cuore- Don Calabria Hospital', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '83100', 'city': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cesare Gridelli, MD', 'role': 'CONTACT', 'email': 'cgridelli@libero.it', 'phone': '0825 203945 - 203573'}, {'name': 'Cesare Gridelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Galetta, MD', 'role': 'CONTACT', 'email': 'galetta@teseo.it', 'phone': '0805555418'}, {'name': 'Sandro Cassiano, Ph', 'role': 'CONTACT', 'email': 'sandrocassiano@libero.it'}, {'name': 'Domenico Galetta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Tumori Giovanni Paolo II', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Mazzoni, MD', 'role': 'CONTACT', 'email': 'francescamazzoni@hotmail.com'}, {'name': 'Francesca Mazzoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '98158', 'city': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Adamo, MD', 'role': 'CONTACT', 'email': 'vadamo@unime.it', 'phone': '+390903996150'}, {'name': 'Vincenzo Adamo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AO Papardo', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Spitalieri, MD', 'role': 'CONTACT', 'email': 'gianluca.spitaleri@ieo.it', 'phone': '+39 02 94372730'}, {'name': 'Gianluca Spitalieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francovito Piantedosi, MD', 'role': 'CONTACT', 'email': 'fvpiantedosi1@tin.it', 'phone': '0817064086/65213'}, {'name': 'Francovito Piantedosi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.R.N dei Colli - Ospedale Monaldi', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Morabito, MD', 'role': 'CONTACT', 'email': 'a.morabito@istitutotumori.na.it', 'phone': '081-5903631'}, {'name': 'Alessandro Morabito, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '07026', 'city': 'Olbia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio Sini', 'role': 'CONTACT', 'email': 'audiosini@tiscali.it'}, {'name': 'Claudio Sini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Giovanni Paolo II ASL-2 Olbia', 'geoPoint': {'lat': 40.92337, 'lon': 9.49802}}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Bonanno, MD', 'role': 'CONTACT', 'email': 'laura.bonanno@iov.veneto.it'}, {'name': 'Laura Bonanno, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alessandro Del Maso, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istituto Oncologico Veneto IRCCS', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '43126', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marcello Tiseo, MD', 'role': 'CONTACT', 'email': 'mtiseo@ao.pr.it', 'phone': '0521702316-702682'}, {'name': 'Marcello Tiseo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera-Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '06132', 'city': 'Perugia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fausto Roila, MD', 'role': 'CONTACT', 'email': 'roila.fausto@libero.it'}, {'name': 'Fausto Roila, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '48121', 'city': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenza Landi, MD', 'role': 'CONTACT', 'email': 'landi.lorenza@gmail.com'}, {'name': 'Michela Spreafico, Biologist', 'role': 'CONTACT', 'email': 'michela.spreafico@irst.emr.it', 'phone': '0544286223'}, {'name': 'Lorenza Landi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale di Ravenna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42123', 'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Pagano, MD', 'role': 'CONTACT', 'email': 'Maria.Pagano@ausl.re.it'}, {'name': 'Maria Pagano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS- Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00128', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Tiseo, MD', 'role': 'CONTACT', 'email': 'g.tonini@unicampus.it'}, {'name': 'Giuseppe Tiseo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Universitario "Campus Biomedico" di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00152', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Rita Migliorino, MD', 'role': 'CONTACT', 'email': 'mmigliorino@scamilloforlanini.rm.it', 'phone': '0658704670'}, {'name': 'Maria Rita Migliorino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera San Camillo-Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '21100', 'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Tuzi, MD', 'role': 'CONTACT', 'email': 'alessandro.tuzi@asst-settelaghi.it'}, {'name': 'Alessandro Tuzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi"', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '37134', 'city': 'Verona', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Santo, MD', 'role': 'CONTACT', 'email': 'antonio.santo@aovr.veneto.it'}, {'name': 'Antonio Santo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Policlinico 'G.B.Rossi' Borgo Roma - Azienda Ospedaliera Universitaria Integrata (Giampaolo Tortora)", 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Federico Cappuzzo, MD', 'role': 'CONTACT', 'email': 'f.cappuzzo@gmail.com', 'phone': '089301545'}, {'name': 'Lorenza Landi, MD', 'role': 'CONTACT', 'email': 'landi.lorenza@gmail.com', 'phone': '089301545'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Ricerca Traslazionale', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}