CClinicalTrials.gg
RecruitingNCT06862869Updated Oct 6, 2026

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

An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Hoffmann-La Roche. Recruiting at 44 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Hoffmann-La Roche · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 800 is above the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Patients participating in interventional study of adjuvant treatment
  • Pregnant, lactating, or breastfeeding women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugAlectinib

    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.

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Duration of alectinib therapy

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 2.5 years

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

    Time frame: Up to approximately 2.5 years

  5. 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)

  6. 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

07

Study locations

43 of 44 sites recruiting
  • Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong 524001, China
    Recruiting
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    Guangzhou, Guangzhou 510095, China
    Recruiting
  • Huai He Hospital of Henan University
    Kaifeng, Henan 475001, China
    Recruiting
  • Henan Provincial Chest Hospital
    Zhengzhou, Henan 450003, China
    Recruiting
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang 830054, China
    Recruiting
  • Peking University First Hospital
    Beijing, 100034, China
    Recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, 100053, China
    Active, not recruiting
  • Hunan Cancer Hospital
    Changsha, 410013, China
    Recruiting
  • Changzhou First People's Hospital
    Changzhou, 213003, China
    Recruiting
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    Chengdu, 610072, China
    Recruiting
  • The First Affiliated Hospital, Chongqing Medical University
    Chongqing, 400016, China
    Recruiting
  • The Second Affiliated Hospital of Dalian Medical University
    Dalian, 116027, China
    Recruiting
  • Fujian Cancer Hospital
    Fuzhou, 350014, China
    Recruiting
  • The Third Affiliated Hospital of Sun Yat-Sen University
    Guangzhou, 510630, China
    Recruiting
  • The Second Affiliated Hospital, Zhejiang University
    Hangzhou, 310009, China
    Recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, 310022, China
    Recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, 150081, China
    Recruiting
  • Anhui Provincial Hospital
    Hefei, 230001, China
    Recruiting
  • Huzhou Central Hospital
    Huzhou, 313000, China
    Recruiting
  • Jiangmen Central Hospital
    Jiangmen, 529030, China
    Recruiting
  • Shandong Provincial Hospital
    Jinan, 250021, China
    Recruiting
  • Lanzhou University Second Hospital
    Lanzhou, 730030, China
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
    Recruiting
  • Jiangsu Cancer Hospital
    Nanjing, 210000, China
    Recruiting
  • Jiangsu Province Hospital
    Nanjing, 210008, China
    Recruiting
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
    Nanjing, 210008, China
    Recruiting
  • Affiliated Hospital of Nantong University
    Nantong, 226001, China
    Recruiting
  • Ningbo No.2 Hospital
    Ningbo, 315000, China
    Recruiting
  • Shanghai Chest Hospital
    Shanghai, 200030, China
    Recruiting
  • Zhongshan Hospital Fudan University
    Shanghai, 200032, China
    Recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, 200433, China
    Recruiting
  • Liaoning Provincial Cancer Hospital
    Shengyang, 110042, China
    Recruiting
  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
    Shenzhen, 518127, China
    Recruiting
  • Hebei Medical University Fourth Hospital
    Shijiazhuang, 50011, China
    Recruiting
  • Shanxi Provincial Cancer Hospital
    Taiyuan, 030013, China
    Recruiting
  • Taizhou Hospital of Zhejiang Province
    Taizhou, 317000, China
    Recruiting
  • Chest disease hospital of Tianjin City
    Tianjin, China
    Recruiting
  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, 430022, China
    Recruiting
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    Wuhan, 430030, China
    Recruiting
  • Wuxi People's Hospital
    Wuxi, 214023, China
    Recruiting
  • The Second Affiliated Hospital of Xi'an Jiao Tong University
    Xi'an, 710004, China
    Recruiting
  • Xi'an International Medical Center Hospital
    Xi'an, 710100, China
    Recruiting
  • General Hospital of Ningxia Medical University
    Yinchuan, 750004, China
    Recruiting
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, 563000, China
    Recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06862869
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Apr 30, 2025
Primary completion
Oct 30, 2029 (estimated)
Completion
Feb 28, 2030 (estimated)
Last update
Oct 6, 2026

Study contacts

Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion