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Carcinoma, Non-Small-Cell LungNCT06862869

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

An observational study of Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 44 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Alectinib
How many people
800 participants
Where
44 sitesChina
Study dates
30 Apr 2025to 28 Feb 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

44 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

44 sites in 1 country

China44 sites, 43 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Active, not recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Recruiting

  • Changzhou First People's Hospital

    Changzhou, 213003

    Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, 610072

    Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

    Recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, 116027

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, 350014

    Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangzhou, 510095

    Recruiting

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630

    Recruiting

  • The Second Affiliated Hospital, Zhejiang University

    Hangzhou, 310009

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • Anhui Provincial Hospital

    Hefei, 230001

    Recruiting

  • Huzhou Central Hospital

    Huzhou, 313000

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, 529030

    Recruiting

  • Shandong Provincial Hospital

    Jinan, 250021

    Recruiting

  • Huai He Hospital of Henan University

    Kaifeng, Henan, 475001

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, 730030

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, 210000

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, 210008

    Recruiting

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, 226001

    Recruiting

  • Ningbo No.2 Hospital

    Ningbo, 315000

    Recruiting

  • Shanghai Chest Hospital

    Shanghai, 200030

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Recruiting

  • Liaoning Provincial Cancer Hospital

    Shengyang, 110042

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

    Shenzhen, 518127

    Recruiting

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, 50011

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317000

    Recruiting

  • Chest disease hospital of Tianjin City

    Tianjin

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Recruiting

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

    Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, 430030

    Recruiting

  • Wuxi People's Hospital

    Wuxi, 214023

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, 710004

    Recruiting

  • Xi'an International Medical Center Hospital

    Xi'an, 710100

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

    Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001

    Recruiting

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan, 450003

    Recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563000

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Alectinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlectinibDrug

    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.

Study groups in NCT06862869
Study groupRoleWhat they receive
Cohort 1Participants 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.
Receives: Drug: Alectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-world disease-free survival (rwDFS)

    Measured: 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 outcomes (6)

  1. Duration of alectinib therapy

    Measured: From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)

  2. Participant demographics by disease stage and city tier

    Measured: Up to approximately 2.5 years

  3. Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier

    Measured: Up to approximately 2.5 years

  4. Participant clinical characteristics as determined by surgery history by disease stage and city tier

    Measured: Up to approximately 2.5 years

  5. Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires

    Measured: At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)

  6. Incidence and severity of adverse events (AEs)

    Measured: Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start30 Apr 2025
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06862869
Sponsor's protocol ID
ML45766
Status last verified
Nov 2026
First submitted
20 Feb 2025
Last updated
5 Nov 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 44 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06862869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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