A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Running, not enrolling · Phase 3
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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.
Key facts
- Study ID
- NCT03456076
- Run by
- Hoffmann-La Roche
- People needed
- 257
- Starts
- 2018-08-16
- Expected to finish
- 2031-11-19
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- MGH Cancer Center — Boston, Massachusetts, United States
- AHN Cancer Institute ? Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
- GenesisCare North Shore — St Leonards, New South Wales, Australia
- Peter MacCallum Cancer Center — Melbourne, Victoria, Australia
- Krankenhaus Nord - Klinik Floridsdorf — Vienna, Austria
- Healthcare Institution Grodno University Hospital — Hrodna, Grodnenskaya, Belarus
- Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary? — Homyel, Homyel'skaya Voblasts', Belarus
- Vitebsk Regional Clinical Oncology Dispensary — Vitebsk, Vitebsk Oblast, Belarus
- Clinical center University of Sarajevo — Sarajevo, Bosnia and Herzegovina
- Beijing Cancer Hospital — Beijing, China
- Jilin Cancer Hospital — Changchun, China
- West China Hospital, Sichuan University — Chengdu, China
- Fujian Medical University Union Hospital — Fujian, China
- Guangdong General Hospital — Guangzhou, China
- Zhejiang Cancer Hospital — Hangzhou, China
- Shandong Cancer Hospital — Jinan, China
- Shanghai Chest Hospital — Shanghai, China
- Zhongshan Hospital Fudan University — Shanghai, China
- Shenzhen People's Hospital — Shenzhen, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University — Xi'an, China
- Odense Universitetshospital, Onkologisk Afdeling R — Odense C, Denmark
- Kasr Eieny Uni Hospital — Cairo, Egypt
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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