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

May 4, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Beijing, China, 100053
        • Active, not recruiting
        • Xuanwu Hospital, Capital Medical University
      • Changsha, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
      • Changzhou, China, 213003
        • Recruiting
        • Changzhou First People's Hospital
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
      • Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital, Chongqing Medical University
      • Dalian, China, 116027
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
      • Fuzhou, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
      • Guangzhou, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University
      • Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
      • Huzhou, China, 313000
        • Recruiting
        • Huzhou Central Hospital
      • Jiangmen, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
      • Jinan, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
      • Lanzhou, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China, 210008
        • Recruiting
        • Jiangsu Province Hospital
      • Nanjing, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Nanjing, China, 210000
        • Recruiting
        • Jiangsu Cancer Hospital
      • Nantong, China, 226001
        • Recruiting
        • Affiliated Hospital of Nantong University
      • Ningbo, China, 315000
        • Recruiting
        • Ningbo No.2 Hospital
      • Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University
      • Shengyang, China, 110042
        • Recruiting
        • Liaoning Provincial Cancer Hospital
      • Shijiazhuang, China, 50011
        • Recruiting
        • Hebei Medical University Fourth Hospital
      • Taiyuan, China, 030013
        • Recruiting
        • Shanxi Provincial Cancer Hospital
      • Taizhou, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
      • Tianjin, China
        • Recruiting
        • Chest disease hospital of Tianjin City
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
      • Wuxi, China, 214023
        • Recruiting
        • Wuxi People's Hospital
      • Xi'an, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital
      • Yinchuan, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
      • Zunyi, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
    • Guangdong
      • Zhanjiang, Guangdong, China, 524001
        • Recruiting
        • Affiliated Hospital of Guangdong Medical University
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510095
        • Recruiting
        • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    • Henan
      • Kaifeng, Henan, China, 475001
        • Recruiting
        • Huai He Hospital of Henan University
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial Chest Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants in China with resected stage II-IIIB ALK-positive NSCLC treated with adjuvant Alectinib according to standard of care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Participants with resected stage II-IIIB ALK-positive NSCLC who have received Alectinib adjuvant therapy will be followed-up for approximately 2.5 years during routine visits at real-world clinical practice settings.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Real-world disease-free survival (rwDFS)
Time Frame: 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)
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)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of alectinib therapy
Time Frame: From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)
From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)
Participant demographics by disease stage and city tier
Time Frame: Up to approximately 2.5 years
Up to approximately 2.5 years
Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier
Time Frame: Up to approximately 2.5 years
Up to approximately 2.5 years
Participant clinical characteristics as determined by surgery history by disease stage and city tier
Time Frame: Up to approximately 2.5 years
Up to approximately 2.5 years
Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires
Time Frame: At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)
At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)
Incidence and severity of adverse events (AEs)
Time Frame: Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first
Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML45766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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