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New study tracks how well alectinib keeps lung cancer from returning after surgery

NCT ID NCT06862869

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 7 times

Summary

This study follows 800 Chinese patients with early-stage ALK-positive non-small-cell lung cancer who took alectinib after surgery to see how long they stay cancer-free. Researchers will collect real-world data on disease-free survival and patient characteristics. The goal is to understand how well alectinib works in everyday clinical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alectinib
What this could lead to
If successful, this study could confirm that alectinib helps prevent lung cancer from returning after surgery in ALK-positive patients, supporting its use in routine care.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It only includes Chinese patients, so findings may not apply globally.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangzhou, 510095, China

  • Affiliated Hospital of Guangdong Medical University

    RECRUITING

    Zhanjiang, Guangdong, 524001, China

  • Affiliated Hospital of Nantong University

    RECRUITING

    Nantong, 226001, China

  • Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, 563000, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, 230001, China

  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

    RECRUITING

    Shenzhen, 518127, China

  • Changzhou First People's Hospital

    RECRUITING

    Changzhou, 213003, China

  • Chest disease hospital of Tianjin City

    RECRUITING

    Tianjin, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, 350014, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, 750004, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, 150081, China

  • Hebei Medical University Fourth Hospital

    RECRUITING

    Shijiazhuang, 50011, China

  • Henan Provincial Chest Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Huai He Hospital of Henan University

    RECRUITING

    Kaifeng, Henan, 475001, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, 410013, China

  • Huzhou Central Hospital

    RECRUITING

    Huzhou, 313000, China

  • Jiangmen Central Hospital

    RECRUITING

    Jiangmen, 529030, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, 210000, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, 210008, China

  • Lanzhou University Second Hospital

    RECRUITING

    Lanzhou, 730030, China

  • Liaoning Provincial Cancer Hospital

    RECRUITING

    Shengyang, 110042, China

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

    RECRUITING

    Nanjing, 210008, China

  • Ningbo No.2 Hospital

    RECRUITING

    Ningbo, 315000, China

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, 250021, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, 200030, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, 200433, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, 030013, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, 610072, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, 317000, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, 830054, China

  • The First Affiliated Hospital, Chongqing Medical University

    RECRUITING

    Chongqing, 400016, China

  • The Second Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, 116027, China

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

    RECRUITING

    Xi'an, 710004, China

  • The Second Affiliated Hospital, Zhejiang University

    RECRUITING

    Hangzhou, 310009, China

  • The Third Affiliated Hospital of Sun Yat-Sen University

    RECRUITING

    Guangzhou, 510630, China

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

    RECRUITING

    Wuhan, 430030, China

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

    RECRUITING

    Wuhan, 430022, China

  • Wuxi People's Hospital

    RECRUITING

    Wuxi, 214023, China

  • Xi'an International Medical Center Hospital

    RECRUITING

    Xi'an, 710100, China

  • Xuanwu Hospital, Capital Medical University

    ACTIVE_NOT_RECRUITING

    Beijing, 100053, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, 310022, China

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, 200032, China

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