Study on NVL-655 for Patients with Advanced Lung Cancer and Other Tumors with ALK Changes (ALKOVE-1)

Sponsor: Nuvalent Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05384626

Provider View

This clinical trial is testing a new drug, NVL-655, to see if it is safe and effective for treating advanced lung cancer and other solid tumors that have specific changes in the ALK gene. The study will determine the best dose and evaluate how well the drug works in shrinking tumors.

Patient Parameters

Program Overview

This study is divided into two phases. Phase 1 will focus on finding out if NVL-655 is safe and what dose should be used in future studies. Phase 2 will look at how well the drug works in shrinking tumors in patients with advanced lung cancer and other solid tumors that have changes in the ALK gene. Researchers will also study how long the response lasts, how quickly it starts, and overall survival rates.

Description

In Phase 2, patients will be divided into six groups based on their previous treatments and type of cancer:

  • Cohort 2a: Patients with advanced lung cancer with ALK changes who have tried one previous ALK-targeted therapy (like ceritinib, alectinib, or brigatinib) and up to two other treatments.
  • Cohort 2b: Patients with advanced lung cancer with ALK changes who have tried two to three ALK-targeted therapies (like crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib) and up to two other treatments.
  • Cohort 2c: Patients with advanced lung cancer with ALK changes who have only tried lorlatinib as an ALK-targeted therapy and up to one other treatment.
  • Cohort 2d: Patients with advanced lung cancer with ALK changes who have not tried any ALK-targeted therapy and up to one other treatment.
  • Cohort 2e: Patients with advanced lung cancer with ALK changes who do not fit into the other groups.
  • Cohort 2f: Patients with other types of solid tumors with ALK changes who have tried at least one other cancer treatment or have no other treatment options available.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older (12 years or older for Cohort 2f) and weigh more than 40 kg.
  • For Phase 1: Must have advanced solid tumors with ALK changes confirmed by lab tests.
  • For Phase 2: Must have advanced lung cancer with ALK changes (except for Cohort 2f, which includes other solid tumors with ALK changes).
  • Must have tumors that can be measured by scans.
  • Must have good organ function and enough healthy blood cells.

Exclusion Criteria

  • Cancer has other known genetic changes besides ALK.
  • Allergic to ingredients in NVL-655.
  • Had major surgery within the last 4 weeks.
  • Currently receiving other cancer treatments.
  • Participating in another clinical trial with active treatment.

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