Neladalkib (NVL-655) for ALK-Positive NSCLC
This study is testing a new drug called neladalkib (NVL-655) for people with advanced non-small cell lung cancer (NSCLC) that has a specific change called an ALK rearrangement. This study is for patients who have not yet received other treatments for their advanced NSCLC. Researchers want to see if neladalkib (NVL-655) is better than a standard treatment, alectinib, at preventing the cancer from growing or spreading. To join, you must have advanced NSCLC with an ALK rearrangement, confirmed by a tissue or blood test, and be at least 18 years old. The study's main goal is to measure how long patients live without their cancer getting worse.
- Study design
- This is a randomized, controlled, open-label study where about 450 participants will be split into two groups, with one group receiving neladalkib (NVL-655) and the other receiving alectinib.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after the first patient receives their medication to see how long they live without their cancer progressing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
At a glance
Conditions
Where it's being run
158 sites across 51 statesStudy leadership
- Kelly Curtis, MD · STUDY_DIRECTOR · Nuvalent Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Progression-free survival (PFS) per blinded independent central review (BICR)Up to 5 years after first patient dosed
Time from randomization to BICR-assessed radiographic disease progression or death