Expanded Access Treatment of Neladalkib (NVL-655) in Patients with Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

Brief description of study

This is a study testing a medicine called Neladalkib (a type of ALK blocker) for patients who have ALK-positive non-small cell lung cancer (NSCLC) that has spread or is hard to treat. This Expanded Access Program gives patients with ALK-positive solid tumors another way to get the medicine Neladalkib if they cannot join a clinical trial or do not have any other good treatment options. Neladalkib works by blocking a protein made by the ALK gene. This protein helps the cancer cells grow and survive. By blocking it, Neladalkib may help stop the cancer from getting worse. Patients will take Neladalkib by mouth, once daily.

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines.The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-00973
ClinicalTrials.gov Identifier: NCT06834074
Principal Investigator: Elaine Shum.
Other Investigators: Samantha VanMaanen, Jessica Wang, Elise Roughan, Salman Rafi Punekar, Joshua K Sabari, Natalia Cherkassky, Rajwanth Veluswamy, Melissa L Martinez, Kirby Rodriguez.


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