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

Inclusion Criteria4

  • 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 Criteria2

  • Patients participating in interventional study of adjuvant treatment
  • Pregnant, lactating, or breastfeeding women

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(36)

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

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 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

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