Evaluating outcomes of ALK-positive lung cancer patients treated with Alectinib after surgery
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
Run by Hoffmann-La Roche · NCT06862869 · Data updated 2026-11-12
This study is testing if Alectinib can help adults with ALK-positive lung cancer feel better after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | Alectinib, chemotherapy |
| Locations | 44 sites (Zhanjiang, Guangdong and 43 other locations) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | October 30, 2029 |
| Study ends | February 28, 2030 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06862869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with histologically-confirmed stage II-IIIB ALK-positive NSCLC who have undergone complete surgical resection.
✕Probably not a fit
Patients who are currently participating in other interventional studies or those who are pregnant, lactating, or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the clinical outcomes and characteristics of adult patients with resected stage II-IIIB ALK-positive non-small-cell lung cancer (NSCLC) who receive Alectinib as adjuvant therapy. Conducted across multiple centers in China, the study will track patients who have undergone complete surgical resection and started Alectinib treatment within 28 days post-surgery. The focus is on understanding the effectiveness and safety of Alectinib in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Alectinib as a post-surgical treatment for ALK-positive NSCLC patients, potentially improving patient outcomes.
How similar studies have gone: While this study focuses on a specific patient population and treatment, similar studies evaluating Alectinib in different contexts have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China Recruiting -
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangzhou, China Recruiting -
Huai He Hospital of Henan University
Kaifeng, Henan, China Recruiting -
Henan Provincial Chest Hospital
Zhengzhou, Henan, China Recruiting -
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China Recruiting -
Peking University First Hospital
Beijing, China Recruiting
Show 38 more locations
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Hunan Cancer Hospital
Changsha, China Recruiting -
Changzhou First People's Hospital
Changzhou, China Recruiting -
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China Recruiting -
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China Recruiting -
The Second Affiliated Hospital of Dalian Medical University
Dalian, China Recruiting -
Fujian Cancer Hospital
Fuzhou, China Recruiting -
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China Recruiting -
The Second Affiliated Hospital, Zhejiang University
Hangzhou, China Recruiting -
Zhejiang Cancer Hospital
Hangzhou, China Recruiting -
Harbin Medical University Cancer Hospital
Harbin, China Recruiting -
Anhui Provincial Hospital
Hefei, China Recruiting -
Huzhou Central Hospital
Huzhou, China Recruiting -
Jiangmen Central Hospital
Jiangmen, China Recruiting -
Shandong Provincial Hospital
Jinan, China Recruiting -
Lanzhou University Second Hospital
Lanzhou, China Recruiting -
The First Affiliated Hospital of Nanchang University
Nanchang, China Recruiting -
Jiangsu Cancer Hospital
Nanjing, China Recruiting -
Jiangsu Province Hospital
Nanjing, China Recruiting -
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, China Recruiting -
Affiliated Hospital of Nantong University
Nantong, China Recruiting -
Ningbo No.2 Hospital
Ningbo, China Recruiting -
Shanghai Chest Hospital
Shanghai, China Recruiting -
Zhongshan Hospital Fudan University
Shanghai, China Recruiting -
Shanghai Pulmonary Hospital
Shanghai, China Recruiting -
Liaoning Provincial Cancer Hospital
Shengyang, China Recruiting -
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
Shenzhen, China Recruiting -
Hebei Medical University Fourth Hospital
Shijiazhuang, China Recruiting -
Shanxi Provincial Cancer Hospital
Taiyuan, China Recruiting -
Taizhou Hospital of Zhejiang Province
Taizhou, China Recruiting -
Chest disease hospital of Tianjin City
Tianjin, China Recruiting -
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China Recruiting -
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China Recruiting -
Wuxi People's Hospital
Wuxi, China Recruiting -
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China Recruiting -
Xi'an International Medical Center Hospital
Xi'an, China Recruiting -
General Hospital of Ningxia Medical University
Yinchuan, China Recruiting -
Affiliated Hospital of Zunyi Medical University
Zunyi, China Recruiting -
Xuanwu Hospital, Capital Medical University
Beijing, China Active not recruiting
Study contacts
- Study coordinator: Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing standard and adjusted doses of alectinib for lung cancer treatment
This study is testing if adjusting the dose of alectinib based on blood levels can help people with ALK positive lung cancer live longer without their disease getting worse compared to the standard dose.
-
Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC
This study tests whether giving amivantamab together with lazertinib or with carboplatin and pemetrexed before surgery can slow or stop tumor growth in people with resectable EGFR-mutated NSCLC.
-
Multidisciplinary treatment planning for older people with lung cancer
We will test a team-based approach that uses geriatric assessments to create personalized treatment plans for people aged 60–90 with newly diagnosed lung cancer to see if it improves 3-year progression-free survival compared with past patients.
-
Dabrafenib and trametinib for rare cancers with BRAF V600 mutations
This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.
-
Intratumoral injection of N17350 in advanced solid tumors
Aims to see if injected N17350 can shrink or control tumors in adults with advanced solid cancers who have few other options.
-
Clinical outcomes of amivantamab-based treatment for advanced EGFR-mutated non-small cell lung cancer in everyday care.
This project will see how amivantamab-containing treatments work for people with advanced non-small cell lung cancer who have common EGFR mutations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.