Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT03321695
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-small-cell Lung']}, 'descriptionModule': {'briefSummary': 'This is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical practice settings in Argentina.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include participants with locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) who have received the indication for treatment with atezolizumab, as per local label (disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence after treatment with a platinum-based adjuvant/neoadjuvant regimen, and have progressed on an appropriate approved targeted therapy if their tumor has EGFR or ALK gene abnormalities) and who have no contraindication to atezolizumab therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)\n* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)\n* Have received at least one dose of atezolizumab as per local label and clinical practice\n\nExclusion Criteria:\n\n* Contraindicated atezolizumab therapy'}, 'identificationModule': {'nctId': 'NCT03321695', 'briefTitle': 'A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Observational Study of the Safety of Atezolizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina', 'orgStudyIdInfo': {'id': 'ML39852'}}, 'contactsLocationsModule': {'locations': [{'zip': 'B1610BAL', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Productos Roche S.A. Quimica e Industrial, División Farmacéutica', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}