Lung Cancer: SAF-189s Phase 3 Trial Reaches Primary Completion

A Phase 3 clinical trial investigating SAF-189s for ALK-positive advanced and metastatic Non-Small Cell Lung Cancer (NSCLC) reached its primary completion on 2025-07-31. The study enrolled 275 participants to compare SAF-189s against crizotinib as a first-line treatment.

Background

Lung cancer remains a leading cause of cancer-related mortality globally. Non-Small Cell Lung Cancer (NSCLC) accounts for the majority of lung cancer cases. A subset of NSCLC patients harbor specific genetic alterations, such as rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene. ALK-positive NSCLC is a distinct molecular subtype that often responds to targeted therapies known as ALK inhibitors. Crizotinib is an established ALK inhibitor used in the treatment of ALK-positive advanced NSCLC. The development of new ALK inhibitors aims to improve efficacy, safety, or overcome resistance mechanisms seen with existing treatments, offering potentially better outcomes for patients.

Trial design

This randomized, multicenter, open-label Phase 3 study, NCT06569420, enrolled 275 participants with treatment-naive ALK-positive advanced Non-Small Cell Lung Cancer. The trial's objective was to evaluate the efficacy and safety of SAF-189s compared to crizotinib. Participants were randomized 1:1 into two treatment groups. One group received SAF-189s at a dose of 160 milligrams once daily orally, while the comparator group received crizotinib at 250 milligrams twice daily orally.

What this means

The primary completion of this Phase 3 trial signifies that data collection for the study's main objectives concerning SAF-189s in ALK-positive advanced NSCLC is now complete. For patients with this specific type of lung cancer, the completion of this trial moves the investigational therapy closer to potential regulatory review and availability, depending on the forthcoming results. The comparison against crizotinib suggests an aim to establish SAF-189s as a potentially improved or alternative first-line treatment option, which could expand the therapeutic landscape for ALK-positive NSCLC patients.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The event, related to study NCT06569420, was recorded on 2025-07-31 on clinicaltrials.gov.