Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06161051
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-treatment discontinuation (TTD)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Real-world overall response rate (rwORR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Proportion of patients with best overall response of either a complete response (CR) or partial response (PR) to the line of therapy based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or per healthcare professional (HCP) assessment.'}, {'measure': 'Real-world disease control rate (rwDCR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Proportion of patients with best overall response of either a CR+PR or stable disease to the line of therapy based on RECIST version 1.1, or per HCP assessment.'}, {'measure': 'Real-world duration of response (rwDOR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Time from the date of first documented CR or PR to the first documented systemic disease progression or death due to any cause.'}, {'measure': 'Real-world progression-free survival (rwPFS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Time from start of therapy until the earliest of a clinically documented systemic disease progression.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'Time from start of therapy until death.'}], 'secondaryOutcomes': [{'measure': 'Number of patients per demographic category', 'timeFrame': 'Baseline', 'description': 'Demographic categories included sex, race/ethnicity, and insurance status.'}, {'measure': 'Mean age', 'timeFrame': 'Baseline'}, {'measure': 'Number of patients per clinical characteristic category', 'timeFrame': 'Baseline', 'description': 'Clinical characteristics included staging, presence and site(s) of metastases, number of lesions, and performance status.'}, {'measure': 'Number of patients per comorbidity', 'timeFrame': 'Up to 6 months pre-baseline'}]}, 'conditionsModule': {'keywords': ['aNSCLC'], 'conditions': ['Advanced Non-small Cell Lung Cancer and MET Exon 14 Skipping Mutation']}, 'descriptionModule': {'briefSummary': 'This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Data abstraction was performed by the participating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient was aged ≥ 18 years at the time of NSCLC diagnosis.\n* Had histologically confirmed advanced (stage IIIB, IIIC, or IV) NSCLC with MET exon 14 skipping mutation.\n* Initiated first-line (1L) treatment for aNSCLC between 1 January 2017 and date of data abstraction with one of the following treatment regimen:\n\n * Capmatinib\n * IO agent in monotherapy (e.g., atezolizumab, pembrolizumab)\n * CT regimen, single agent or combinations of CT agents (e.g., platinum agents, taxane agents, gemcitabine, pemetrexed)\n * Combination regimen containing IO and CT agents\n* Had ≥ 6 months of potential follow-up time after the initiation of 1L treatment for aNSCLC, except if the patient died sooner.\n* Living or deceased at the time of chart abstraction.\n\nExclusion Criteria:\n\n* Presence of other mutations (e.g., EGFR, ALK, ROS1, RET, NTRK, BRAF, or KRAS) at any time.\n* Treatment with other MET inhibitors such as crizotinib or tepotinib at any time during the study period.\n* Participation in clinical trials related to treatment for NSCLC at any timepoint.'}, 'identificationModule': {'nctId': 'NCT06161051', 'briefTitle': 'Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States', 'orgStudyIdInfo': {'id': 'CINC280AUS16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Capmatinib'}, {'label': 'IO monotherapy'}, {'label': 'Chemotherapy alone'}, {'label': 'IO + chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}