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Nuvalent Alkazar-NVL-655 vs Alectinib 1st line treatment for ALK+ Non-Small Cell Lung cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the most effective, safe dose of an experimental drug called NVL-655 (the study drug). We want to know how well the study drug works compared to alectinib, which is a standard treatment for NSCLC.

What is the Condition Being Studied?

ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with locally advanced or metastatic NSCLC
  • Have a documented ALK rearrangement in tissue or blood
  • Have not received prior systemic anticancer treatment for NSCLC

For more information, contact the study team at annemarie.peters@duke.edu.

Grupo etario
Adultos

What is Involved?

If you choose to join this study, you will get a random assignment (by chance) to 1 of 2 study groups, Arm A or Arm B.

  • If you are in Arm A, you will get the study drug. The study drug comes as a tablet, and you will take it by mouth once per day.
  • If you are in Arm B, you will get alectinib. Alectinib is a capsule. You will take it by mouth twice a day.

During the study visits the following procedures may occur: physical examinations, eye examinations, vital signs recording, blood and urine samples collected, electrocardiograms, imaging (CT or MRI) scans, tumor samples, and questionnaires.

The duration of your participation in the study will depend on how long you receive study drug, the overall duration of the study, and how long you are willing to participate. If the research study is stopped prematurely for any reason, your study doctor will tell you and arrange your continuing care.

Study Details

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)
Principal Investigator
Especialista en oncología médica
Protocol Number
IRB: PRO00117309
NCT: NCT06765109
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción