Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT06862869
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582670', 'term': 'alectinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real-world disease-free survival (rwDFS)', 'timeFrame': 'From baseline to the date of the first documentation of cancer recurrence, as determined by the physician according to local clinical standard of care, or death due to any cause, whichever occurs first (up to approximately 2.5 years)'}], 'secondaryOutcomes': [{'measure': 'Duration of alectinib therapy', 'timeFrame': 'From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)'}, {'measure': 'Participant demographics by disease stage and city tier', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Participant clinical characteristics as determined by surgery history by disease stage and city tier', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires', 'timeFrame': 'At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)'}, {'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in China with resected stage II-IIIB ALK-positive NSCLC treated with adjuvant Alectinib according to standard of care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC/AJCC), 8th edition\n* ALK positive\n* Postoperative NSCLC patients who have undergone complete resection\n* Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days\n\nExclusion Criteria:\n\n* Patients participating in interventional study of adjuvant treatment\n* Pregnant, lactating, or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06862869', 'briefTitle': 'Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'ML45766'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Participants with resected stage II-IIIB ALK-positive NSCLC who have received Alectinib adjuvant therapy will be followed-up for approximately 2.5 years during routine visits at real-world clinical practice settings.', 'interventionNames': ['Drug: Alectinib']}], 'interventions': [{'name': 'Alectinib', 'type': 'DRUG', 'description': 'Participants will have received alectinib adjuvant treatment for resected stage II-IIIB ALK-positive NSCLC in routine clinical practice.\n\nNOTE: No intervention will be provided in this study as the study is observational.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Henan Provincial Chest Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '100034', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100053', 'city': 'Beijing', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '213003', 'city': 'Changzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': "Changzhou First People's Hospital", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '400016', 'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital, Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510630', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310022', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '150081', 'city': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '230001', 'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '313000', 'city': 'Huzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Huzhou Central Hospital', 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}, {'zip': '529030', 'city': 'Jiangmen', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Jiangmen Central Hospital', 'geoPoint': {'lat': 22.58333, 'lon': 113.08333}}, {'zip': '250021', 'city': 'Jinan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '730030', 'city': 'Lanzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Lanzhou University Second Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '210008', 'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210008', 'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '226001', 'city': 'Nantong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '200433', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '110042', 'city': 'Shengyang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Liaoning Provincial Cancer Hospital', 'geoPoint': {'lat': 28.01749, 'lon': 119.37448}}, {'zip': '50011', 'city': 'Shijiazhuang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hebei Medical University Fourth Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '030013', 'city': 'Taiyuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shanxi Provincial Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '317000', 'city': 'Taizhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Taizhou Hospital of Zhejiang Province', 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Chest disease hospital of Tianjin City', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '430030', 'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '214023', 'city': 'Wuxi', 'status': 'RECRUITING', 'country': 'China', 'facility': "Wuxi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '750004', 'city': 'Yinchuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '563000', 'city': 'Zunyi', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}], 'centralContacts': [{'name': 'Reference Study ID Number: ML45766 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728 (U.S. and Canada)'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}