Anaplastic lymphoma kinase gene mutation Trials in Disease

Study Comparing Alectinib and Crizotinib for Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer

This trial focuses on patients with advanced non-small cell lung cancer that has a specific genetic change called ALK-positive. The cancer cells in these patients have a mutation in the anaplastic lymphoma kinase gene, which can drive cancer growth. The study compares two oral medications: Alectinib (also known as Alecensa) and Crizotinib (known as XALKORI).

Main inclusion criteria:

• Confirmed diagnosis of advanced or returning ALK-positive non-small cell lung cancer that has spread and cannot be treated with multiple treatment types
• The cancer must be measurable in size using specific criteria
• No previous whole-body treatments for advanced or returning disease
• Good overall health status with an ECOG Performance Score of 0-2, meaning patients can perform most daily activities
• Normal blood, kidney, and liver function
• If cancer has spread to the brain, it must not be causing symptoms, or symptoms must be controlled and stable for at least 14 days after treatment

Main exclusion criteria:

• Previous treatment specifically for ALK-positive non-small cell lung cancer
• Other serious medical conditions that could interfere with the study or pose safety risks
• Pregnancy or breastfeeding
• Inability to follow study procedures
• History of certain heart problems
• Active infections requiring treatment
• Recent participation in another clinical trial

Focus and goals: The main goal of this study is to evaluate which of the two medications is more effective at controlling the cancer without it worsening. This is measured by progression-free survival. The trial also looks at how long it takes for the cancer to spread to the brain, overall survival, quality of life, and side effects. Participants are randomly assigned to receive either Alectinib or Crizotinib and will have regular check-ups to monitor their health and how the cancer responds to treatment.

Investigational drugs: Both Alectinib and Crizotinib are tyrosine kinase inhibitors that work by blocking the activity of the ALK protein. By inhibiting this protein, the medications aim to slow down or stop the growth and spread of cancer cells. Both drugs are taken orally as capsules according to the study protocol.

The trial is expected to continue until September 2026, allowing researchers to gather comprehensive information about the long-term effectiveness and safety of these treatments for patients with this specific type of lung cancer.