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

September 3, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

  • Name: Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below.
  • Phone Number: 888-662-6728 (U.S. and Canada)
  • Email: global-roche-genentech-trials@gene.com

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
      • Shenzhen, China, 518127
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
      • 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, 430022
        • Recruiting
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • 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
      • Xi'an, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiao Tong University
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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