Clinical trial Recruiting at 43 sites Observational Ages 18 and up

Evaluating outcomes of ALK-positive lung cancer patients treated with Alectinib after surgery

Official title: 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

Run by Hoffmann-La Roche · NCT06862869 · Data updated 2026-11-12

This study is testing if Alectinib can help adults with ALK-positive lung cancer feel better after their surgery.

More Carcinoma, Non-Small-Cell Lung trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorHoffmann-La Roche
Industry-sponsored
Drugs / interventionsAlectinib, chemotherapy
Locations44 sites (Zhanjiang, Guangdong and 43 other locations)
StatusRecruiting
StartedApril 30, 2025
Main results expectedOctober 30, 2029
Study endsFebruary 28, 2030
Registry record updatedNovember 5, 2026
Trial IDNCT06862869 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults with histologically-confirmed stage II-IIIB ALK-positive NSCLC who have undergone complete surgical resection.

Probably not a fit

Patients who are currently participating in other interventional studies or those who are pregnant, lactating, or breastfeeding may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the clinical outcomes and characteristics of adult patients with resected stage II-IIIB ALK-positive non-small-cell lung cancer (NSCLC) who receive Alectinib as adjuvant therapy. Conducted across multiple centers in China, the study will track patients who have undergone complete surgical resection and started Alectinib treatment within 28 days post-surgery. The focus is on understanding the effectiveness and safety of Alectinib in this specific patient population.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Alectinib as a post-surgical treatment for ALK-positive NSCLC patients, potentially improving patient outcomes.

How similar studies have gone: While this study focuses on a specific patient population and treatment, similar studies evaluating Alectinib in different contexts have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China
    Recruiting
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    Guangzhou, Guangzhou, China
    Recruiting
  • Huai He Hospital of Henan University
    Kaifeng, Henan, China
    Recruiting
  • Henan Provincial Chest Hospital
    Zhengzhou, Henan, China
    Recruiting
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang, China
    Recruiting
  • Peking University First Hospital
    Beijing, China
    Recruiting
Show 38 more locations
  • 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
  • The Second Affiliated Hospital of Xi'an Jiao Tong University
    Xi'an, China
    Recruiting
  • Xi'an International Medical Center Hospital
    Xi'an, China
    Recruiting
  • General Hospital of Ningxia Medical University
    Yinchuan, China
    Recruiting
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, China
    Recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, China
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.