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Clinical Trials in China / NCT06862869
Recruiting Observational

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
2026-10-06

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
No
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)

FacilityCityRegionStatus
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.

More Hoffmann-La Roche trials in China

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors Active, not recruiting
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer Active, not recruiting
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes Recruiting
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study Recruiting
A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Active, not recruiting

Other trials for the same condition

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC Recruiting
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Active, not recruiting
SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009) Recruiting
ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007) Recruiting
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer Active, not recruiting
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