A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Alectnib: Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Cisplatin: Participants will receive Cisplatin 75 milligrams per square meter (mg/m\^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
Vinorelbine: Participants will receive Vinorelbine 25 mg/m\^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Gemcitabine: Participants will receive Gemcitabine 1250 mg/m\^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Pemetrexed: Participants will receive 500 mg/m\^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
Carboplatin: For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Disease-free Survival (DFS), as Assessed by the Investigator — Approximately 58 months
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
Trial sites (114)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Austria | |
| 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 | 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 | |
| CHU Angers | Angers | France | |
| Hopital Nord AP-HM | Marseille | France | |
| Hopital Bichat Claude Bernard | Paris | France | |
| Institut Gustave Roussy | Villejuif | France | |
| Klinikum Chemnitz gGmbH | Chemnitz | Germany | |
| Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH | Georgsmarienhütte | Germany | |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | Germany | |
| Fachklinik für Lungenerkrankungen | Immenhausen | Germany | |
| Metropolitan Hospital | Athens | Greece | |
| Theageneio Hospital | Thessaloniki | Greece | |
| Orszagos Onkologiai Intezet | Budapest | Hungary | |
| Hetenyi Geza County Hospital | Szolnok | Hungary | |
| Rambam Health Care Campus | Haifa | Israel | |
| Meir Medical Center | Kfar Saba | Israel | |
| Az. Osp. Monaldi | Naples | Campania |
+ 74 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03456076 on ClinicalTrials.gov ↗ ← All trials in Denmark