Alectinib versus crizotinib in previously untreated patients with ALK-positive non-small cell lung cancer.

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2013-004133-33-PL
• Date of registration: 10/06/2014
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: Alectinib versus crizotinib in previously untreated patients with ALK-positive non-small cell lung cancer.
• Scientific title: RANDOMIZED, MULTICENTER, PHASE III, OPEN LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT NAÏVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER
• Date of first enrolment: 28/07/2014
• Target sample size: 286
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004133-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Thailand, Turkey, Ukraine, United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
•Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK FISH is required. Both tests will be performed at designated central laboratories.
•Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
•Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
•ECOG PS of 0 2.
•Adequate hematologic, renal and liver function.
•Able and willing to provide written informed consent prior to performing any study related procedures and to comply with the study protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion criteria:
•Any GI disorder that may affect absorption of oral medications, such as mal absorption syndrome or status post-major bowel resection.
•Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib or crizotinib except for oral corticosteroids up to 20 mg of prednisolone equivalent per day.
•Administration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug and while on treatment.
•History of hypersensitivity to any of the additives in the alectinib drug formulation (lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, sodium lauryl sulfate [SLS], magnesium stearate).
•History of hypersensitivity to any of the additives in the crizotinib drug formulation (silica, colloidal anhydrous cellulose, microcrystalline calcium hydrogen phosphate, anhydrous sodium starch glycolate, magnesium stearate).
•Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

ALK-positive non-small cell lung cancer

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Alectinib
Product Code: RO5424802
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Alectinib
Current Sponsor code: Ro542-4802/F03
Other descriptive name: ALK INHIBITOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Xalkori
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Crizotinib
CAS Number: 877399-52-5
Other descriptive name: Crizotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Trade Name: Xalkori
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Crizotinib
CAS Number: 877399-52-5
Other descriptive name: Crizotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Main Objective: Investigator assessed progression-free survival (PFS)

Timepoint(s) of evaluation of this end point: The time from date of randomization to the date of first documented disease progression (as per RECIST 1.1) or death, whichever occurs first

Primary end point(s): PFS

Secondary Objective: PFS by the IRC; time to CNS progression; Objective Response Rate (ORR) and Duration of Response (DOR); time to deterioration (TTD) in patient-reported lung cancer symptoms; health-related quality of life (HRQoL); safety and tolerability; pharmacokinetics of alectinib and metabolite(s); overall survival (OS).

Secondary Outcome(s)

Secondary end point(s): •PFS by IRC
•Time to CNS Progression
•ORR
•Time to deterioration (TTD) in patient-reported lung cancer symptoms
•Health-related quality of life (HRQoL)
•Safety and tolerability
•Pharmacokinetics of alectinib and metabolite(s)
•Overall survival (OS)

Timepoint(s) of evaluation of this end point: •The same methodology as specified for PFS
•The time from randomization until radiographic evidence of CNS
progression
•The percentage of patients who attain a CR or PR (as per RECIST 1.1)
•From baseline until disease progression and during post-progression on
treatment in case of isolated, asymptomatic CNS progression; and at
survival follow-up for 6 months
•From baseline until disease progression and during post-progression on
treatment in case of isolated, asymptomatic CNS progression; and at
survival follow-up for 6 months
•Throughout the study
•Until disease progression
•The time from the date of randomization to the date of death due to any
cause

Secondary ID(s)

BO28984

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd