Phase 12 Study of Neladalkib NVL-655 for Treating Advanced ALK-Positive NSCLC and Other Solid Tumors

What this Trial Is About

Researchers are evaluating neladalkib NVL-655, an oral drug, in a Phase 12 study for patients with advanced ALK-positive non-small cell lung cancer NSCLC and other solid tumors. The study aims to assess the safety and tolerability of neladalkib, determine the recommended phase 2 dose, and evaluate its antitumor activity. A sub-study also investigates potential interactions between neladalkib and other drugs such as midazolam, repaglinide, and itraconazole in patients with advanced ALK-positive NSCLC. The study includes Phase 1 dose escalation to find the safe dose and Phase 2 dose expansion with six patient groups based on prior treatments and tumor types. Patients receive daily oral neladalkib. The sub-study enrolls patients into two cohorts to study drug interactions involving midazolam, repaglinide, and itraconazole. Eligible patients may have received various prior therapies including ALK tyrosine kinase inhibitors TKIs, chemotherapy, or immunotherapy depending on their cohort. Participants will undergo regular assessments such as scans and lab tests to monitor disease response and safety. Researchers will measure outcomes including dose limiting toxicities, objective response rate, duration of response, progression-free survival, overall survival, and quality of life over approximately three years. The study also monitors drug levels and adverse events closely, including in the drug interaction sub-study, with follow-up extending to months after the last dose.

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)