Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

NCT06862869 · tracked via the Priya Life Science China tracker

Sponsor

Hoffmann-La Roche

Phase

Observational

Started

2025-04-30

Last updated

2026-09-08

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Alectinib

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Patients participating in interventional study of adjuvant treatment * Pregnant, lactating, or breastfeeding women

Primary outcome measure(s)

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)

Trial sites (44)

Facility	City	Region	Status
Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong	Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou	Guangzhou	Recruiting
Huai He Hospital of Henan University	Kaifeng	Henan	Recruiting
Henan Provincial Chest Hospital	Zhengzhou	Henan	Recruiting
The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	Recruiting
Peking University First Hospital	Beijing	China	Recruiting
Xuanwu Hospital, Capital Medical University	Beijing	China	Active Not Recruiting
Hunan Cancer Hospital	Changsha	China	Recruiting
Changzhou First People's Hospital	Changzhou	China	Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital	Chengdu	China	Recruiting
The First Affiliated Hospital, Chongqing Medical University	Chongqing	China	Recruiting
The Second Affiliated Hospital of Dalian Medical University	Dalian	China	Recruiting
Fujian Cancer Hospital	Fuzhou	China	Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	China	Recruiting
The Second Affiliated Hospital, Zhejiang University	Hangzhou	China	Recruiting
Zhejiang Cancer Hospital	Hangzhou	China	Recruiting
Harbin Medical University Cancer Hospital	Harbin	China	Recruiting
Anhui Provincial Hospital	Hefei	China	Recruiting
Huzhou Central Hospital	Huzhou	China	Recruiting
Jiangmen Central Hospital	Jiangmen	China	Recruiting
Shandong Provincial Hospital	Jinan	China	Recruiting
Lanzhou University Second Hospital	Lanzhou	China	Recruiting
The First Affiliated Hospital of Nanchang University	Nanchang	China	Recruiting
Jiangsu Cancer Hospital	Nanjing	China	Recruiting
Jiangsu Province Hospital	Nanjing	China	Recruiting
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing	China	Recruiting
Affiliated Hospital of Nantong University	Nantong	China	Recruiting
Ningbo No.2 Hospital	Ningbo	China	Recruiting
Shanghai Chest Hospital	Shanghai	China	Recruiting
Zhongshan Hospital Fudan University	Shanghai	China	Recruiting
Shanghai Pulmonary Hospital	Shanghai	China	Recruiting
Liaoning Provincial Cancer Hospital	Shengyang	China	Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center	Shenzhen	China	Recruiting
Hebei Medical University Fourth Hospital	Shijiazhuang	China	Recruiting
Shanxi Provincial Cancer Hospital	Taiyuan	China	Recruiting
Taizhou Hospital of Zhejiang Province	Taizhou	China	Recruiting
Chest disease hospital of Tianjin City	Tianjin	China	Recruiting
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan	China	Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	China	Recruiting
Wuxi People's Hospital	Wuxi	China	Recruiting

+ 4 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06862869 on ClinicalTrials.gov ↗ ← All trials in China