RecruitingNCT06862869

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

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study

Sponsor

Hoffmann-La Roche

Enrollment

800 participants

Start Date

Apr 30, 2025

Study Type

OBSERVATIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study is tracking how patients with early-to-mid stage non-small cell lung cancer (NSCLC) whose tumors have an ALK gene change respond to a drug called alectinib taken after surgery (adjuvant therapy) outside of a clinical trial setting. **You may be eligible if...** - You have stage II–IIIB (T3N2) NSCLC confirmed by tissue biopsy - Your tumor is ALK-positive (a specific gene change) - You have had complete surgical removal of your tumor - You have been prescribed alectinib as your first and only post-surgery treatment - You started alectinib within the last 28 days **You may NOT be eligible if...** - You are enrolled in another clinical trial for adjuvant treatment - You are pregnant, breastfeeding, or lactating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlectinib

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.

Locations(40)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

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

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

Fujian Cancer Hospital

Fuzhou, China

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

The Second Affiliated Hospital, Zhejiang University

Hangzhou, 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

The First Affiliated Hospital of Nanchang University

Nanchang, 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

Ningbo No.2 Hospital

Ningbo, China

Shanghai Chest Hospital

Shanghai, China

Zhongshan Hospital Fudan University

Shanghai, 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

View Full Details on ClinicalTrials.gov

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NCT06862869