Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT07239102
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}], 'ancestors': [{'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iPFS', 'timeFrame': 'From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025', 'description': 'According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the Response Assessment in Neuro-Oncology (RANO) criteria, the intracranial progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts'}], 'secondaryOutcomes': [{'measure': 'iDCR', 'timeFrame': 'Within the study period from January 1, 2020 and May 30, 2025', 'description': 'For different cohorts, evaluate the intracranial objective response rate (iORR) and disease control rate (iDCR) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) positive for EGFR mutations and presenting with central nervous system metastases'}, {'measure': 'PFS', 'timeFrame': 'From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025', 'description': 'According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) the progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts'}, {'measure': 'OS', 'timeFrame': 'From first dose until death, assessed between January 1, 2020 and May 30, 2025', 'description': 'measured from the date of first-line treatment initiation to the date of documented death'}, {'measure': 'DOR', 'timeFrame': 'Within the study period from January 1, 2020 and May 30, 2025', 'description': 'defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria, assessed at the first radiologic evaluation following initiation of treatment'}, {'measure': 'TTR', 'timeFrame': 'assessed during the study period from January 1, 2020 and May 30, 2025.', 'description': 'Defined as the time from the initiation of treatment to the date of first documented objective response (CR or PR) according to RECIST 1.1 criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['EGFR Positive Non-small Cell Lung Cancer', 'Central Nervous System Metastasis', 'Leptomeningeal Metastasis']}, 'descriptionModule': {'briefSummary': 'This is a clinical retrospective study that will collect and analyze clinical data from all patients treated with fumeitinib mesylate in the Oncology Department of Tiantan Hospital between January 1, 2020 and May 31, 2025. The data collection will include general demographic characteristics (gender, age, family history, smoking history, etc.), clinicopathological features, NGS test reports, fumeitinib initiation time and dosage, concomitant medications, local treatments (surgery, radiotherapy, etc.), and baseline and follow-up imaging examinations related to efficacy and safety. The study will conduct: 1) clinical data analysis; and 2) exploration of resistance-related clinical characteristics and influencing factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have received at least one treatment cycle of Firmonertinib are defined as the Full Analysis Set (FAS). Except for specially specified study endpoints (such as DOR which is evaluated only in the population achieving objective response), the primary endpoints, secondary endpoints, and safety endpoints of the study are evaluated in the FAS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed stage IIIb-IVb NSCLC or postoperative recurrent NSCLC;\n2. Positive EGFR test result, which can be determined by methods such as RT-PCR/FISH/IHC/NGS from hospital laboratories or testing institutions;\n3. Patients aged ≥18 years;\n4. Patients have clinically received Firmonertinib treatment, with recorded objective efficacy evaluation and adverse reactions;\n5. Sign the Beijing Tiantan Hospital broad informed consent form.\n\nExclusion Criteria:\n\n\\- Patients who cannot provide follow-up data for at least one cycle.'}, 'identificationModule': {'nctId': 'NCT07239102', 'briefTitle': 'Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'A Real-World Clinical Retrospective Study of Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis', 'orgStudyIdInfo': {'id': 'HX-B-2025058'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EGFR-mutated NSCLC with brain metastases', 'interventionNames': ['Drug: Firmonertinib']}, {'label': 'EGFR-mutated NSCLC with leptomeningeal metastases', 'interventionNames': ['Drug: Firmonertinib']}], 'interventions': [{'name': 'Firmonertinib', 'type': 'DRUG', 'description': 'Firmonertinib any dose, oral', 'armGroupLabels': ['EGFR-mutated NSCLC with brain metastases', 'EGFR-mutated NSCLC with leptomeningeal metastases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Li Xiaoyan', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}