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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
257
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.
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."
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.
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.
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."
For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.
Rush University Medical Center
Chicago, Illinois, United States
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
Disease-free Survival (DFS), as Assessed by the Investigator
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
Time frame: Approximately 58 months
Overall Survival (OS)
Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.
Time frame: From the date of randomization until death due to any cause up to approximately 8 years
Percentage of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
Plasma Concentration of Alectinib
Time frame: Predose (2 hours) Week 3 - Week 96
Plasma Concentration of Alectinib Metabolite M4
Time frame: Predose (2 hours) Week 3 - Week 96
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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
...and 104 more locations