Phase II Clinical Trial NCT05384626 by Nuvalent, Inc. A Study of NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Who is this trial for: NVL-655 is a 4th generation, brain-penetrant, ALK TKI inhibitor created to overcome several limitations observed with currently available therapies. NVL-655 is designed to have activity in tumors that have developed resistance to first, second, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R/L1196M (“GRLM”), G1202R/G1269A (“GRGA”), or G1202R/L1198F (“GRLF”). In other words, it is for patients for whom other ALK TKIs have failed under certain conditions.

Clinical TrialsKirk SmithNovember 5, 2024Clinical Trials, Nuvalent, NVL-655, ALKOVE-1

ALKOVE Clinical Trial, a 4th Generation TKI from Nuvalent

The Phase 1/2 trial of Nuvalent, Inc.’s NVL-655, the fourth generation ALK TKI, has begun at Sarah Cannon Research Institute in Nashville, soon to be followed by additional locations. For patients currently on Lorlatinib, NVL-655 provides a hope-filled option for those who test positive for certain mutations that are common upon progression on Lorlatinib. The trial is also open to a range of patients described below that are progressing after other treatment options.

Clinical TrialsKirk SmithJuly 18, 2022Clinical Trials, Nuvalent, ALKOVE-1