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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world disease-free survival (rwDFS) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of alectinib therapy | From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years) | |
| Participant demographics by disease stage and city tier | Up to approximately 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in China with resected stage II-IIIB ALK-positive NSCLC treated with adjuvant Alectinib according to standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Guangdong Medical University | Recruiting | Zhanjiang | Guangdong | 524001 | China | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier | Up to approximately 2.5 years |
| Participant clinical characteristics as determined by surgery history by disease stage and city tier | Up to approximately 2.5 years |
| Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires | At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years) |
| Incidence and severity of adverse events (AEs) | Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University |
| Recruiting |
| Guangzhou |
| Guangzhou |
| 510095 |
| China |
| Huai He Hospital of Henan University | Recruiting | Kaifeng | Henan | 475001 | China |
| Henan Provincial Chest Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 830054 | China |
| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
| Xuanwu Hospital, Capital Medical University | Active, not recruiting | Beijing | 100053 | China |
| Hunan Cancer Hospital | Recruiting | Changsha | 410013 | China |
| Changzhou First People's Hospital | Recruiting | Changzhou | 213003 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Recruiting | Chengdu | 610072 | China |
| The First Affiliated Hospital, Chongqing Medical University | Recruiting | Chongqing | 400016 | China |
| The Second Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | 116027 | China |
| Fujian Cancer Hospital | Recruiting | Fuzhou | 350014 | China |
| The Third Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | 510630 | China |
| The Second Affiliated Hospital, Zhejiang University | Recruiting | Hangzhou | 310009 | China |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | 150081 | China |
| Anhui Provincial Hospital | Recruiting | Hefei | 230001 | China |
| Huzhou Central Hospital | Recruiting | Huzhou | 313000 | China |
| Jiangmen Central Hospital | Recruiting | Jiangmen | 529030 | China |
| Shandong Provincial Hospital | Recruiting | Jinan | 250021 | China |
| Lanzhou University Second Hospital | Recruiting | Lanzhou | 730030 | China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
| Jiangsu Cancer Hospital | Recruiting | Nanjing | 210000 | China |
| Jiangsu Province Hospital | Recruiting | Nanjing | 210008 | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Recruiting | Nanjing | 210008 | China |
| Affiliated Hospital of Nantong University | Recruiting | Nantong | 226001 | China |
| Ningbo No.2 Hospital | Recruiting | Ningbo | 315000 | China |
| Shanghai Chest Hospital | Recruiting | Shanghai | 200030 | China |
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | 200032 | China |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | 200433 | China |
| Liaoning Provincial Cancer Hospital | Recruiting | Shengyang | 110042 | China |
| Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center | Recruiting | Shenzhen | 518127 | China |
| Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | 50011 | China |
| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | 030013 | China |
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | 317000 | China |
| Chest disease hospital of Tianjin City | Recruiting | Tianjin | China |
| Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | 430022 | China |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology | Recruiting | Wuhan | 430030 | China |
| Wuxi People's Hospital | Recruiting | Wuxi | 214023 | China |
| The Second Affiliated Hospital of Xi'an Jiao Tong University | Recruiting | Xi'an | 710004 | China |
| Xi'an International Medical Center Hospital | Recruiting | Xi'an | 710100 | China |
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | 750004 | China |
| Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | 563000 | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C582670 | alectinib |
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