Neladalkib for Non-Small Cell Lung Cancer

(ALKAZAR Trial)

This trial tests a new drug, neladalkib (also known as NVL-655), to determine if it can help people with Non-Small Cell Lung Cancer (NSCLC) live longer without their cancer worsening. The trial compares neladalkib to alectinib, aiming to discover if neladalkib is more effective at delaying cancer progression in patients who have not yet received treatment for their ALK-positive advanced lung cancer. Suitable participants have NSCLC with an ALK rearrangement, have not undergone prior systemic cancer treatment, and have at least one measurable tumor. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have had prior treatment with ALK inhibitors like alectinib.

Earlier research has shown that neladalkib (NVL-655) demonstrates promising safety results in people with advanced non-small cell lung cancer (NSCLC) with a specific genetic change called ALK-positive. Patients generally tolerated the treatment well, even those who had undergone several other treatments. Most reported side effects were mild or moderate, meaning they weren't too severe or difficult to manage.

Neladalkib specifically targets cancer cells with the ALK gene change, potentially reducing unwanted effects on other cells in the body. While some side effects may still occur, current data suggests that neladalkib has a promising safety profile.

Alectinib, the other treatment under study, is already FDA-approved for ALK-positive NSCLC, indicating its safety has been thoroughly researched and is well understood. Common side effects include tiredness, constipation, and swelling in the hands, feet, and face, but these are usually manageable.

Neladalkib (NVL-655) stands out because it targets specific mutations in non-small cell lung cancer (NSCLC) more precisely than existing treatments like alectinib. Unlike standard options, which generally inhibit a range of ALK mutations, Neladalkib is designed to be more selective, potentially reducing side effects by sparing non-cancerous cells. Researchers are excited because this targeted approach could offer a more effective treatment with fewer adverse reactions, providing a significant advance for patients with ALK-positive NSCLC.

Research has shown that neladalkib (NVL-655), one of the treatments studied in this trial, could be a promising option for people with advanced ALK-positive Non-Small Cell Lung Cancer (NSCLC). Early results indicate that neladalkib has been effective in patients with advanced or spreading ALK-positive tumors, suggesting it might help prevent the cancer from worsening. In this trial, some participants will receive Alectinib, the current standard treatment, which has proven effective in similar cases. Neladalkib aims to extend the time before the cancer worsens even further. Overall, evidence suggests neladalkib could be a strong option for patients with this type of lung cancer.¹²⁶⁷⁸