Study of NVL-520 for Patients with Advanced Lung Cancer and Other Solid Tumors with ROS1 Rearrangement

Sponsor: Nuvalent Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05118789

Provider View

This clinical trial is testing a new drug, NVL-520, to see if it is safe and effective for treating advanced lung cancer and other solid tumors that have a specific genetic change called ROS1 rearrangement.

Patient Parameters

Program Overview

The study is divided into two phases. Phase 1 will focus on finding the safest dose of NVL-520 for patients with advanced solid tumors that have the ROS1 rearrangement. Phase 2 will evaluate how well the drug works in shrinking tumors in patients with advanced lung cancer and other solid tumors that are ROS1-positive. Researchers will also look at how long the treatment works, how quickly it starts to work, and overall survival rates.

Description

In Phase 2 of the study, patients will be divided into five groups based on their previous treatments:

  • Group 2a: Patients with ROS1-positive lung cancer who have not received any Tyrosine Kinase Inhibitor (TKI) therapy and have had up to one prior chemotherapy or immunotherapy.
  • Group 2b: Patients with ROS1-positive lung cancer who have been treated with one ROS1 TKI but no chemotherapy or immunotherapy.
  • Group 2c: Patients with ROS1-positive lung cancer who have been treated with one ROS1 TKI and one platinum-based chemotherapy, with or without immunotherapy.
  • Group 2d: Patients with ROS1-positive lung cancer who have been treated with two or more ROS1 TKIs and up to one prior chemotherapy or immunotherapy.
  • Group 2e: Patients with ROS1-positive solid tumors other than lung cancer who have progressed after any prior therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older (for Group 2e, patients can be 12 years or older and weigh more than 40 kg).
  • Must have a confirmed diagnosis of advanced or metastatic solid tumor with ROS1 rearrangement.
  • For Phase 2, must have advanced or metastatic lung cancer with ROS1 rearrangement (Groups 2a, 2b, 2c, 2d) or another solid tumor with ROS1 rearrangement (Group 2e).
  • Must have had prior cancer treatment, except for Group 2a.
  • Must have measurable disease according to specific medical criteria.
  • Must have adequate organ function and bone marrow health.

Exclusion Criteria

  • Cancer has a known genetic change other than ROS1.
  • Known allergy to ingredients in NVL-520.
  • Major surgery within four weeks before starting the study drug.
  • Currently receiving other cancer treatments.
  • Participating in another clinical study with active treatment.

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