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

Recruiting now

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT06862869

Run by

Hoffmann-La Roche

People needed

800

Starts

2025-04-30

Expected to finish

2029-04-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Affiliated Hospital of Zunyi Medical University — Zunyi, China (enrolling)
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangzhou, China (enrolling)
• Huai He Hospital of Henan University — Kaifeng, Henan, China (enrolling)
• Henan Provincial Chest Hospital — Zhengzhou, Henan, China (enrolling)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (enrolling)
• Peking University First Hospital — Beijing, China (enrolling)
• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (enrolling)
• Hunan Cancer Hospital — Changsha, China (enrolling)
• Changzhou First People's Hospital — Changzhou, China (enrolling)
• Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, China (enrolling)
• The First Affiliated Hospital, Chongqing Medical University — Chongqing, China (enrolling)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, China (enrolling)
• The Third Affiliated Hospital of Sun Yat-Sen University — Guangzhou, China (enrolling)
• The Second Affiliated Hospital, Zhejiang University — Hangzhou, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, China (enrolling)
• Anhui Provincial Hospital — Hefei, China (enrolling)
• Huzhou Central Hospital — Huzhou, China (enrolling)
• Jiangmen Central Hospital — Jiangmen, China (enrolling)
• Shandong Provincial Hospital — Jinan, China (enrolling)
• Lanzhou University Second Hospital — Lanzhou, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (enrolling)
• Jiangsu Cancer Hospital — Nanjing, China (enrolling)
• Jiangsu Province Hospital — Nanjing, China (enrolling)

Full record on ClinicalTrials.gov

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