A Phase I Study of NVL-655 in People with Advanced Non-Small Cell Lung Cancer or Other Solid Tumors


Full Title

NVL-655-01, A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)


The purpose of this study is to find the highest dose of the investigational drug NVL-655 that can be given safely in people with advanced non-small cell lung cancer (NSCLC) or other solid tumors that contain a genetic change called an ALK gene fusion. NVL-655 is a type of drug called a tyrosine kinase inhibitor (TKI), which works by blocking proteins that fuel cancer growth. However, some cancer cells develop resistance to TKI treatment.

Researchers think that NVL-655 may be an effective therapy for people with advanced or metastatic solid tumors with an ALK fusion because NVL-655 may continue to work after cancer cells develop resistance to other TKI treatments. NVL-655 is a tablet that is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have NSCLC or another solid tumor that continues to grow despite prior treatment and contains an ALK gene fusion.
  • People with NSCLC must have previously received another ALK TKI treatment, such as ceritinib, alectinib, brigatinib, or lorlatinib.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older, although one study group will include people age 12 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Alexander Drilon at 646-608-3758.




Phase I/II (phases 1 and 2 combined)



ClinicalTrials.gov ID