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A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)
EU CTIS ID: 2023-506859-13-00
What this study is testing
To evaluate and compare the efficacy of alectinib compared with crizotinib in patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC), as measured by investigator-assessed progression-free survival (PFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 immunohistochemistry (IHC) test. Sufficient tumor tissue to perform ALK IHC and ALK fluorescent in situ hybridization (FISH) is required. Both tests will be performed at designated central laboratories.
- Measurable disease (by Response Evaluation Criteria In Solid Tumors [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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
- Adequate hematologic, renal and liver function.
- 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 as 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.
You likely can't join if
- 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 gastrointestinal (GI) disorder that may affect absorption of oral medications, such as mal absorption syndrome or status post-major bowel resection
- National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) Grade 3 or higher toxicities due to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
- Liver disease - ALT or AST > 3 x upper limit of normal OR - Impaired excretory function OR - Acute viral or active autoimmune alcoholic, or other types of acute hepatitis Patients with baseline QTc > 470 ms or symptomatic bradycardia
- 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.
- Administration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug for all patients and while on treatment through the end of the study for crizotinib-treated patients only
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Canada
- Taiwan
- Australia
- Israel
- Brazil
- Turkey
- China
- Ukraine
- United States
- Thailand
- Singapore
- Korea, Republic of
- Serbia
- Mexico
- Guatemala
- Chile
- New Zealand
- United Kingdom
- Costa Rica
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Canada; Taiwan; Australia; Israel; Brazil and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.