Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
1 other identifier
observational
800
1 country
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
May 5, 2026
May 1, 2026
3.5 years
February 20, 2025
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (6)
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
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)
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
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
Participants in China with resected stage II-IIIB ALK-positive NSCLC treated with adjuvant Alectinib according to standard of care.
You may qualify if:
- 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
- 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
You may not qualify if:
- Patients participating in interventional study of adjuvant treatment
- Pregnant, lactating, or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangzhou, 510095, China
Huai He Hospital of Henan University
Kaifeng, Henan, 475001, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Peking University First Hospital
Beijing, 100034, China
Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
Hunan Cancer Hospital
Changsha, 410013, China
Changzhou First People's Hospital
Changzhou, 213003, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, 116027, China
Fujian Cancer Hospital
Fuzhou, 350014, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510630, China
The Second Affiliated Hospital, Zhejiang University
Hangzhou, 310009, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Anhui Provincial Hospital
Hefei, 230001, China
Huzhou Central Hospital
Huzhou, 313000, China
Jiangmen Central Hospital
Jiangmen, 529030, China
Shandong Provincial Hospital
Jinan, 250021, China
Lanzhou University Second Hospital
Lanzhou, 730030, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, 210000, China
Jiangsu Province Hospital
Nanjing, 210008, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
Ningbo No.2 Hospital
Ningbo, 315000, China
Shanghai Chest Hospital
Shanghai, 200030, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Liaoning Provincial Cancer Hospital
Shengyang, 110042, China
Hebei Medical University Fourth Hospital
Shijiazhuang, 50011, China
Shanxi Provincial Cancer Hospital
Taiyuan, 030013, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317000, China
Chest disease hospital of Tianjin City
Tianjin, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
Wuxi People's Hospital
Wuxi, 214023, China
Xi'an International Medical Center Hospital
Xi'an, 710100, China
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
Affiliated Hospital of Zunyi Medical University
Zunyi, 563000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: ML45766 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2025
First Posted
March 6, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
April 30, 2029
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share