RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT-NAÏVE ANAPLASTIC LYMPHOMA KINASE−POSITIVE ADVANCED NON−SMALL CELL LUNG CANCER

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-064-14
• Date of registration: 20/03/2015
• Prospective Registration: Yes
• Primary sponsor: F. HOFFMANN-LA ROCHE LTD.,
• Public 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
• 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: 15/09/2015
• Target sample size: 8
• Recruitment status: Pending
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=064-14
• Study type: Interventional
• Study design: This study will comprise approximately 180 centers, in around 30 countries worldwide.; Central randomization will be performed via an interactive voice or web-based response system (IxRS) using the following stratification factors: Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no). An IxRS manual containing relevant information will be provided to each study site.; The experimental arm will receive alectinib at 600 mg orally twice daily (BID), taken with food.; The control arm will receive crizotinib at 250 mg orally BID, taken with or without food.; Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent, or death. After progression (as per RECIST v1.1), patients should discontinue the study medication. After disease progression, patients will be treated at the discretion of the investigator according to local
• Phase: III

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea North, Macedonia, New Zealand, Panama, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States

Contacts

• Name: Roberto Navarro Carrasco
• Affiliation: PRODUCTOS ROCHE Q.F.S.A.

• Name: Roberto Navarro Carrasco
• Affiliation: PRODUCTOS ROCHE Q.F.S.A.

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.
• Age ≥ 18 years old.
• Life expectancy of at least 12 weeks.
• ECOG PS of 0-2.
• Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not
amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
• Adequate hematologic function:
Platelet count ≥ 100 × 109/L
ANC ≥ 1500 cells/μL
Hemoglobin ≥ 9.0 g/dL
• Adequate renal function:
Calculated creatinine clearance at least 45 mL/min
• Patients must have recovered from effects of any major surgery or significant traumatic
injury at least 28 days before the first dose of study treatment.
• Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
• Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed
incidentally at study baseline. If patients have neurological symptoms or signs due to CNS
metastasis, patients need to complete whole brain radiation or gamma knife irradiation
treatment at least 14 days before enrollment and be clinically stable.
• For all females of childbearing potential, a negative pregnancy test must be obtained within
3 days before starting study treatment.
• For women who are not postmenopausal ( ≥ 12 months of non-therapy-induced amenorrhea)
or surgically sterile (absence of ovaries and/or uterus).

Exclusion criteria:
Patients with a previous malignancy within the past 3 years are excluded (other than
curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by
endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered
to have no impact in PFS and OS for the current NSCLC).
• Any GI disorder that may affect absorption of oral medications, such as mal-absorption
syndrome or status post-major bowel resection.
• Liver disease characterized by:
ALT or AST > 3 × ULN (≥ 5 × ULN for patients with concurrent liver metastasis)
confirmed on two consecutive measurements
OR
Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other
conditions of decompensated liver disease such as coagulopathy, hepatic
encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices
OR
Acute viral or active autoimmune, alcoholic, or other types of hepatitis
• National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding
alopecia), which have not shown improvement and are strictly considered to interfere with
current study medication.
• History of organ transplant.
• Co-administration of anti-cancer therapies other than those administered in this study.
• Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia < 45 beats
per minute.
• 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).
• Pregnant or lactating women.
• Known HIV positivity or AIDS-related illness.


Age minimum: 18
Age maximum: 80
Gender: --

Health Condition(s) or Problem(s) studied

-C34 Malignant neoplasm of bronchus and lung
Malignant neoplasm of bronchus and lung

C34

Malignant neoplasm of bronchus and lung

Intervention(s)

The experimental arm will receive alectinib at 600 mg orally twice daily (BID), taken with food.
The control arm will receive crizotinib at 250 mg orally BID, taken with or without food.

Source(s) of Monetary Support

Industria Farmaceutica

Ethics review

Status: Approved
Approval date: 28/08/2014
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 07/01/2015
Contact:

[e-mail]; [e-mail]

Hospital Nacional Carlos Alberto Seguin Escobedo - Arequipa

959383952

[e-mail]; [e-mail]

Status: Approved
Approval date: 12/03/2015
Contact:

[e-mail]

Instituto Nacional de Enfermedades Neoplasicas

7106099-3001

[e-mail]