Study on Neladalkib (NVL-655) for Patients with Untreated Advanced ALK-Positive Non-Small Cell Lung Cancer

Sponsor: Nuvalent Inc.

Sponsor score: 60

ClinicalTrials ID:NCT06765109

Provider View

This clinical trial is comparing a new drug, neladalkib (NVL-655), to alectinib to see which is better at delaying the progression of advanced ALK-positive Non-Small Cell Lung Cancer in patients who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if the new drug neladalkib (NVL-655) is more effective than alectinib in slowing down the progression of advanced Non-Small Cell Lung Cancer (NSCLC) that is positive for the ALK gene. This study involves patients who have not received any previous treatment for their lung cancer.

Description

In this study, patients will be randomly assigned to one of two groups. One group will receive the new drug neladalkib (NVL-655), and the other group will receive alectinib. There will be about 225 patients in each group. The goal is to see which drug is better at keeping the cancer from getting worse over time.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC) that cannot be treated with surgery or other combined treatments.
  • Have a positive test for the ALK gene rearrangement in their cancer.
  • Have not received any previous systemic treatment for NSCLC, except for chemotherapy given more than 12 months ago.
  • Have at least one tumor that can be measured by scans.
  • Provide a sample of tumor tissue for testing.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2, meaning fully active or with some limitations but able to care for oneself.

Exclusion Criteria

  • Have a different known genetic change in the cancer other than ALK.
  • Have an allergy to the ingredients in neladalkib or alectinib.
  • Have had recent or ongoing radiation therapy that does not meet the study's time requirements.
  • Have had major surgery within the last 4 weeks.
  • Have an uncontrolled infection that requires treatment.
  • Have active tuberculosis or hepatitis B or C.
  • Have a heart condition that affects the heart's electrical activity, with a QTcF greater than 470 milliseconds.
  • Have significant heart disease.
  • Have brain metastases causing worsening symptoms or needing more steroids to manage.
  • Have another active cancer that required treatment within the last 2 years.

Locations

FACILITYZIPCITYSTATE
Clinical Research Alliance Inc.11042New Hyde ParkNew York

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