Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 12:31 AM
Study NCT ID:
NCT06644495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of adverse drug reactions in the overall population', 'timeFrame': 'At enrollment and every 3 months thereafter (up to 3 years)'}], 'secondaryOutcomes': [{'measure': 'The incidence of greater than or equal to grade 3 AEs, SAEs, AEs resulting in dose reduction/interruption/discontinuation, AESIs, and AEs resulting in death in the overall population', 'timeFrame': 'At enrollment and every 3 months thereafter (up to 3 years)'}, {'measure': 'Real-world progression-free survival (rwPFS) for 1L treatment with Iruplinalkib', 'timeFrame': 'From the first administration of Iruplinalkib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 3 years).'}, {'measure': 'Time to treatment failure (TTF) for 1L treatment with Iruplinalkib', 'timeFrame': 'From the first administration of Iruplinalkib to the date of first documentation of discontinuation of Iruplinalkib due to any cause (up to 3 years).'}, {'measure': 'Event to first follow-up treatment or death (TFST) for 1L treatment with Iruplinalkib', 'timeFrame': 'From the first administration of Iruplinalkib to the date of first documentation of initiation of next line of treatment, or death due to any cause, whichever occurs first (up to 3 years).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with Iruplinalkib or planned to receive Iruplinalkib treatment in real-world clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALK-positive advanced non-small cell lung cancer patients who are being treated with Iruplinalkib or planned to receive Iruplinalkib.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed patients with locally-advanced or metastatic ALK-positive non-small cell lung cancer.\n* Currently receiving, or planned to receive treatment with Iruplinalkib.\n* Subjects had imaging reports of chest and abdominal enhanced CT and brain MRI within 42 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.\n* Subjects had routine and biochemical reports within 30 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.\n\nExclusion Criteria:\n\n* Patients who had previously been treated with ALK-TKI, but who had previously only been treated with ALK-TKI as neoadjuvant and/or adjunctive treatment could be enrolled.\n* Mental disorder or inability to cooperate with examination or follow-up.\n* Women known to be pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT06644495', 'briefTitle': 'Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib', 'orgStudyIdInfo': {'id': 'IRU-PMS-001'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'CaiCun Zhou, PhD', 'role': 'CONTACT', 'email': 'caicunzhoudr@163.com', 'phone': '+86-021-65115006-3050'}, {'name': 'Wei Li, PhD', 'role': 'CONTACT', 'email': 'leewluck@gmail.com', 'phone': '021-38804518-22113'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}