NVL-655 vs Alectinib in First-line ALK-positive Non-small Cell Lung Cancer Patients (ALKAZAR)

• Research type

  Research Study

• Full title

  A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

• IRAS ID

  1004185

• Contact name

  Virginia Vetter

• Contact email

  medical@nuvalent.com

• Sponsor organisation

  Nuvalent, Inc

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT06765109

• Research summary

  Nuvalent Inc. is sponsoring this clinical trial to investigate a new drug called NVL-655 in the treatment of non-small cell lung cancer (NSCLC) which has spread outside the lungs, and where a change in a gene called anaplastic lymphoma kinase (ALK) has occurred.
  This study aims to see whether NVL-655 is better than the usual treatment, alectinib, in the treatment of patients with ALK-positive NSCLC. This will be done mainly by looking at how long study participants go without experiencing a worsening of their cancer, when receiving NVL-655 in comparison to alectinib.
  This study will have approximately 450 participants with NSCLC from research sites all over the world.
  The study will have 2 groups, Arm A and Arm B. Participants will be randomly assigned to a treatment arm.
  • Arm A: Participants receive NVL-655 in tablet form, to be taken by mouth once a day.
  • Arm B: Participants receive alectinib in capsule form to be taken by mouth twice a day.
  Participants will also need to undergo a biopsy, to take a sample of tumour tissue for analysis. During the treatment period, participants will undergo tests and procedures including blood and urine tests, participant questionnaires and physical examinations, as well as regular scans to measure and take pictures of the size of their cancer.
  A follow-up period will follow in which participants will be asked to return to the study site for a final visit, contacted via telephone 30 days later and then approximately every 3 months after that to continue to check on their wellbeing.
  The duration of participation in the study will depend on how long a participant receives the study drug, the overall duration of the study, and how long they are willing to participate.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  25/LO/0269

• Date of REC Opinion

  7 May 2025

• REC opinion

  Further Information Favourable Opinion