Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT06269133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real-world response rate (rwRR)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Any treatment-emergent immune-mediated adverse event (imAE)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Any treatment-emergent imAE resulting in hospitalization', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Any treatment-emergent imAE resulting in death', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Specific treatment-emergent imAEs', 'timeFrame': 'Approximately 3 years'}], 'secondaryOutcomes': [{'measure': 'Real-world duration of response (rwDOR)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Real-world progression-free survival (rwPFS)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Real-world overall survival (rwOS)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Treatment-emergent immune-mediated adverse events (imAEs)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'Infusion-related reaction (IRR)', 'timeFrame': 'Approximately 3 years'}, {'measure': 'IRR resulting in hospitalization', 'timeFrame': 'Approximately 3 years'}, {'measure': 'IRR resulting in death', 'timeFrame': 'Approximately 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced non-small cell lung cancer (aNSCLC)', 'Epidermal growth factor receptor (EGFR)', 'Anaplastic lymphoma kinase (ALK)', 'C-ros oncogene receptor tyrosine kinase (ROS1)'], 'conditions': ['Advanced Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases.', 'detailedDescription': 'Patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced disease, defined as stage IIIB, IIIC, or IV disease, with evidence of administration of 1L cemiplimab in combination with platinum-doublet chemotherapy between 08 Nov 2022 and 30 Jun 2026 and without EGFR, ALK, or ROS1 genomic variants, or actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1\\. Advanced non-small cell lung cancer (aNSCLC) (defined as stage IIIB/C or stage IV) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1L setting from Nov 2022 to Jun 2026 as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Patients who have EGFR, ALK or ROS1 variants\n2. Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date\n3. Patients actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy\n\nNote: Other protocol-defined Inclusion/ Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT06269133', 'briefTitle': 'Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'Evaluating the Safety and Effectiveness of Cemiplimab in Combination With Platinum-Doublet Chemotherapy by Demographic Characteristics in First-Line Treatment of Advanced Non-Small Cell Lung Cancer: A Multi-Database Real World Evidence Study in US Patients', 'orgStudyIdInfo': {'id': 'R2810-ONC-22115'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Patients', 'description': 'Patients who have received cemiplimab in combination with platinum-doublet chemotherapy for the 1L treatment of aNSCLC in the US with no documented EGFR, ALK and ROS1 variants as described in the protocol.', 'interventionNames': ['Drug: REGN2810', 'Other: Platinum-doublet chemotherapy']}], 'interventions': [{'name': 'REGN2810', 'type': 'DRUG', 'otherNames': ['LIBTAYO®', 'cemiplimab'], 'description': 'No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.', 'armGroupLabels': ['Study Patients']}, {'name': 'Platinum-doublet chemotherapy', 'type': 'OTHER', 'description': 'No study specific interventions for this non-interventional-observational study; patients had previously been administered this treatment.', 'armGroupLabels': ['Study Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}