Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 8:29 AM
Study NCT ID:
NCT04667234
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2025-08-13
First Post:
2020-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access of Sotorasib
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706028', 'term': 'sotorasib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}, 'nPtrsToThisExpAccNctId': 5}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['NSCLC', 'KRAS p.G12C Mutation'], 'conditions': ['Non Small-cell Lung Cancer', 'Locally Advanced Unresectable NSCLC', 'Locally Advanced Metastatic NSCLC']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18 years\n* Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product\n* Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing\n* Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n\nExclusion Criteria\n\n* Mixed small-cell lung cancer or mixed NSCLC histology\n* Active brain metastases\n* Active hepatitis B or hepatitis C virus\n* Current active malignancy other than NSCLC\n* Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval\n* Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib'}, 'identificationModule': {'nctId': 'NCT04667234', 'briefTitle': 'Expanded Access of Sotorasib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation', 'orgStudyIdInfo': {'id': '20190436'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AMG 510', 'type': 'DRUG', 'otherNames': ['Sotorasib', 'Lumakras (US)', 'Lumykras (UK)'], 'description': 'Administered as an oral tablet.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 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