ALEX Study: A Randomized, Phase III Study Comparing Alectinib with Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients


About this study

This randomized, active controlled, multicenter Phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with critozinib treatment in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized in a 1:1 ratio to receive either alectinib, 600 mg orally twice daily (BID), or critozinib, 250 mg orally BID. Patients will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death occurs. The study is expected to last approximately 42 months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
  • 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 renal, hematologic and liver function
  • 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 (e.g., diagnosed incidentally at study baseline). Asymptomatic CNS lesions might be treated at the discretion of the investigator per local clinical practice. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment. In all cases, radiation treatment must be completed at least 14 days before enrollment and patients must be clinically stable
  • Use of highly effective contraception as defined by the study protocol

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 on PFS and OS for the current NSCLC)
  • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (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
  • Co-administration of anti-cancer therapies other than those administered in this study.
  • Patients with baseline QTc > 470 ms or symptomatic bradycardia
  • Receipt of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment except for oral corticosteroids up to 20 mg of prednisolone equivalent per day
  • Receipt of any drug with potential QT interval prolonging effects within 14 days prior to the first dose until the end of study treatment
  • Pregnant or breast-feeding women
  • Any clinically significant disease or condition (or history of) 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Helen Ross, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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