Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 4:04 PM
Study NCT ID:
NCT05285033
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RW Effectiveness of Lurbinectedin in Extensive Stage SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568606', 'term': 'PM 01183'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'demographic and clinical characteristics of patients', 'timeFrame': '8 months', 'description': 'age'}, {'measure': 'demographic and clinical characteristics of patients', 'timeFrame': '8 months', 'description': 'sex'}, {'measure': 'demographic and clinical characteristics of patients', 'timeFrame': '8 months', 'description': 'clinical stage'}, {'measure': 'demographic and clinical characteristics of patients', 'timeFrame': '8 months', 'description': 'prior therapy'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '8 months', 'description': 'OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause'}, {'measure': 'Real-world progression-free survival', 'timeFrame': '8 months', 'description': 'time from first dose of treatment with lurbinectedin to first occurrence of disease progression or death from any cause during the study'}, {'measure': 'Best response', 'timeFrame': '8 months', 'description': 'best response recorded from the start of treatment with lurbinectedin until disease progression or start of further anti-cancer treatment'}, {'measure': 'Duration of treatment', 'timeFrame': '8 months', 'description': 'time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin'}, {'measure': 'Pattern of tumor progression', 'timeFrame': '8 months', 'description': 'site of disease progression after treatment with lurbinectedin'}, {'measure': 'Duration of treatment with lurbinectedin beyond progression', 'timeFrame': '8 months', 'description': 'time between first occurrence of disease progression and treatment discontinuation'}, {'measure': 'Adverse Drug Reaction', 'timeFrame': '8 months', 'description': 'maximal grade 3-4-5 treatment-related adverse events (SAEs, TRAEs), and immune-related events will be recorded for each patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IFCT', 'Small-cell Lung Cancer', 'Lurbinectedin', 'Real-world study'], 'conditions': ['Small-cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '32224306', 'type': 'BACKGROUND', 'citation': "Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27."}], 'seeAlsoLinks': [{'url': 'https://www.ifct.fr/etudes-cliniques/806-ifct-2105', 'label': 'IFCT website'}]}, 'descriptionModule': {'briefSummary': 'LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate effectiveness and safety of lurbinectedin in real-world conditions.', 'detailedDescription': 'LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received lurbinectedin as part of the French Early Access Program (ATU). Previous and subsequent treatments (treatment delivered immediately after treatment with lurbinectedin) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer\n* Patients who were informed about the study and accepted for their data to be collected\n* Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).\n* Selection period spans from June 2020 until March 2021 for initiation of treatment with lurbinectedin.\n\nExclusion Criteria:\n\n* Patients enrolled in a clinical trial assessing treatment with lurbinectedin'}, 'identificationModule': {'nctId': 'NCT05285033', 'acronym': 'LURBICLIN', 'briefTitle': 'RW Effectiveness of Lurbinectedin in Extensive Stage SCLC', 'organization': {'class': 'OTHER', 'fullName': 'Intergroupe Francophone de Cancerologie Thoracique'}, 'officialTitle': 'Real-world Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Lurbinectedin as Part of the French Early Access Program (ATU).', 'orgStudyIdInfo': {'id': 'IFCT-2105'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lurbinectedin', 'type': 'DRUG', 'description': 'Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'Villefranche-Sur-Saône - CH', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'overallOfficials': [{'name': 'Nicolas Girard', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Curie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intergroupe Francophone de Cancerologie Thoracique', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groupe Francais De Pneumo-Cancerologie', 'class': 'OTHER'}, {'name': 'PharmaMar', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}