Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
NCT ID: NCT06862869
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2025-04-30
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
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.
Alectinib
Participants will have received alectinib adjuvant treatment for resected stage II-IIIB ALK-positive NSCLC in routine clinical practice.
NOTE: No intervention will be provided in this study as the study is observational.
Interventions
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Alectinib
Participants will have received alectinib adjuvant treatment for resected stage II-IIIB ALK-positive NSCLC in routine clinical practice.
NOTE: No intervention will be provided in this study as the study is observational.
Eligibility Criteria
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Inclusion Criteria
* ALK positive
* Postoperative NSCLC patients who have undergone complete resection
* 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
Exclusion Criteria
* Pregnant, lactating, or breastfeeding women
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangzhou, China
Huai He Hospital of Henan University
Kaifeng, Henan, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Peking University First Hospital
Beijing, , China
Xuanwu Hospital, Capital Medical University
Beijing, , China
Changzhou First People's Hospital
Changzhou, , China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, , China
The Second Affiliated Hospital of Dalian Medical University
Dalian, , China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
Huzhou Central Hospital
Huzhou, , China
Jiangmen Central Hospital
Jiangmen, , China
Shandong Provincial Hospital
Jinan, , China
Lanzhou University Second Hospital
Lanzhou, , China
Jiangsu Cancer Hospital
Nanjing, , China
Jiangsu Province Hospital
Nanjing, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Affiliated Hospital of Nantong University
Nantong, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Liaoning Provincial Cancer Hospital
Shengyang, , China
Hebei Medical University Fourth Hospital
Shijiazhuang, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
Chest disease hospital of Tianjin City
Tianjin, , China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
Xi'an International Medical Center Hospital
Xi'an, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Affiliated Hospital of Zunyi Medical University
Zunyi, , China
Countries
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Central Contacts
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Reference Study ID Number: ML45766 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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ML45766
Identifier Type: -
Identifier Source: org_study_id
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