A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer (NCT03456076)
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Who can join: Review the eligibility criteria below.
Location: Rush University Medical Center — Chicago, Illinois
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (114 Sites)
Showing the first 25 of 114 sites.
- Rush University Medical Center — Chicago, Illinois
- MGH Cancer Center — Boston, Massachusetts
- AHN Cancer Institute ? Allegheny General Hospital — Pittsburgh, Pennsylvania
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- GenesisCare North Shore — St Leonards, New South Wales
- Peter MacCallum Cancer Center — Melbourne, Victoria
- Krankenhaus Nord - Klinik Floridsdorf — Vienna,
- Healthcare Institution Grodno University Hospital — Hrodna, Grodnenskaya
- Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary? — Homyel, Homyel'skaya Voblasts'
- Vitebsk Regional Clinical Oncology Dispensary — Vitebsk, Vitebsk Oblast
- Clinical center University of Sarajevo — Sarajevo,
- Beijing Cancer Hospital — Beijing,
- Jilin Cancer Hospital — Changchun,
- West China Hospital, Sichuan University — Chengdu,
- Fujian Medical University Union Hospital — Fujian,
- Guangdong General Hospital — Guangzhou,
- Zhejiang Cancer Hospital — Hangzhou,
- Shandong Cancer Hospital — Jinan,
- Shanghai Chest Hospital — Shanghai,
- Zhongshan Hospital Fudan University — Shanghai,
- Shenzhen People's Hospital — Shenzhen,
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan,
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University — Xi'an,
- Odense Universitetshospital, Onkologisk Afdeling R — Odense C,
- Kasr Eieny Uni Hospital — Cairo,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.