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Evaluating outcomes of ALK-positive lung cancer patients treated with Alectinib after surgery

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

Hoffmann-La Roche · NCT06862869

This study is testing if Alectinib can help adults with ALK-positive lung cancer feel better after their surgery.

Quick facts

Study typeObservational
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche (industry)
Drugs / interventionsAlectinib, chemotherapy
Locations41 sites (Zhanjiang, Guangdong and 40 other locations)
Trial IDNCT06862869 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with histologically-confirmed stage II-IIIB ALK-positive NSCLC who have undergone complete surgical resection.

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.

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 performed: While this study focuses on a specific patient population and treatment, similar studies evaluating Alectinib in different contexts have shown promising results.

Eligibility criteria

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 this trial is running

Zhanjiang, Guangdong and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Carcinoma, Non-Small-Cell Lung

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.