Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-09 @ 2:51 AM
Study NCT ID:
NCT05991895
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2023-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
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': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': "This study is a national multicenter real-world investigation aimed at evaluating the real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in China.\n\nThe study aims to enroll ALK-positive NSCLC patients who have undergone treatment with Iruplinalkib prior to enrollment. Demographic information, medical history, Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related data will be collected for all enrolled patients.\n\nAs this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. The primary sources of data for this study will mainly consist of patients' routine medical records or healthcare documentation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ALK-positive non-small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients willingly contribute their clinical data for this study\n* Patients with ALK-positive non-small cell lung cancer\n* Age ≥ 18 years\n* Patients who have undergone treatment with Iruplinalkib.\n\nExclusion Criteria:\n\n* Known pregnant or lactating females\n* Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.'}, 'identificationModule': {'nctId': 'NCT05991895', 'briefTitle': 'Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'IRU-RWS-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Iruplinalkib', 'type': 'DRUG', 'description': 'Iruplinalkib is administered orally with approximately fixed dosing times each day. The recommended dosage is once daily, on an empty stomach or with food, at 60 mg per dose for the first 1 to 7 days. If tolerated, the dosage is increased to 180 mg per dose starting from the 8th day.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linlin Wang', 'role': 'CONTACT', 'email': 'wanglinlinatjn@163.com', 'phone': '+8613793187739'}], 'facility': 'Shandong Cancer Hospital and Institute', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Jinming Yu, PhD', 'role': 'CONTACT', 'email': 'jn7984729@public.jn.sd.cn', 'phone': '8613806406293'}, {'name': 'Linlin Wang, PhD', 'role': 'CONTACT', 'email': 'wanglinlinatjn@163.com', 'phone': '8613793187739'}], 'overallOfficials': [{'name': 'JinMing Yu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Cancer Hospital and Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinming Yu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the hospital', 'investigatorFullName': 'Jinming Yu', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}