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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as advanced ROS1-positive non-small cell lung cancer (NSCLC) and other similar advanced solid tumors. The treatment being tested is a medication called NVL-520, which is taken in the form of a tablet. NVL-520 is a highly selective inhibitor, meaning it specifically targets the ROS1 protein that is involved in the growth of these cancer cells.

The purpose of the study is to determine the most suitable dose of NVL-520 for patients with these types of cancers and to evaluate how effective it is in treating them. The study is divided into two phases. In the first phase, researchers aim to find the right dose of NVL-520 that patients can tolerate. In the second phase, they will assess how well this dose works in treating patients with advanced ROS1-positive NSCLC.

Participants in the study will take NVL-520 orally, and their health will be monitored closely throughout the trial. The study will look at various aspects, such as the safety of the medication and any side effects that may occur. The trial is expected to continue until the end of 2025, providing valuable information on the potential benefits of NVL-520 for patients with these specific types of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical condition. The study is for individuals with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors.

    Participants must have a confirmed diagnosis of a locally advanced or metastatic solid tumor with a documented ROS1 rearrangement.

  2. Step 2

    Phase 1 treatment

    The initial phase involves determining the recommended dose of the medication NVL-520. This phase assesses the safety and tolerability of the drug.

    Participants receive NVL-520 in tablet form, taken orally. The dosage and frequency are adjusted to find the most effective and safe dose.

  3. Step 3

    Phase 2 treatment

    In this phase, the effectiveness of NVL-520 is evaluated at the recommended dose determined in Phase 1.

    The focus is on measuring the overall response rate (ORR) in patients with advanced ROS1-positive NSCLC.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, regular monitoring occurs to assess the safety and effectiveness of the treatment. This includes tracking any side effects and changes in health status.

    Participants undergo various tests and assessments to measure the drug's impact on their condition.

  5. Step 5

    Completion of the trial

    The trial is estimated to conclude by December 21, 2025. Participants will have completed all required treatments and assessments by this time.

    Final evaluations are conducted to gather comprehensive data on the treatment's effectiveness and safety.

Who can join the trial?

8 criteria

  • Must be at least 18 years old. For a specific group in Phase 2, participants can be as young as 12 years old if they weigh more than 40 kg.
  • Must have a type of cancer called a solid tumor that is locally advanced or has spread to other parts of the body. This tumor must have a specific change called a ROS1 rearrangement, which is a change in the genes of the cancer cells.
  • For Phase 1, the cancer must be confirmed through tests called histology or cytology, which are ways to look at cells under a microscope.
  • For certain groups in Phase 2, the cancer must also be confirmed through histology or cytology and have the ROS1 rearrangement.
  • Must have had some form of cancer treatment before joining the study.
  • For Phase 1, the cancer must be evaluable, meaning it can be assessed using specific criteria called RECIST 1.1, which is a way to measure how the cancer responds to treatment.
  • For Phase 2, the cancer must be measurable, meaning there is at least one area of cancer that can be measured using scans or other tests, according to RECIST 1.1.
  • Must provide a sample of the tumor tissue before starting the study treatment.

Who cannot join the trial?

4 criteria

  • Patients who do not have **advanced ROS1-positive NSCLC** or other **advanced ROS1-positive solid tumors** cannot participate. **NSCLC** stands for **non-small cell lung cancer**, and **ROS1-positive** means the cancer has a specific genetic change.
  • Patients who are not within the specified age ranges cannot participate. The age ranges include children, adults, and older adults.
  • Patients who are not male or female cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.
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Investigated drugs

NVL-520 is a medication being studied for its potential to treat patients with advanced solid tumors that are positive for ROS1, a specific type of genetic alteration. This medication is a highly selective inhibitor, meaning it specifically targets and blocks the activity of the ROS1 protein, which may help to slow down or stop the growth of cancer cells. The trial aims to find the most effective dose of NVL-520 and to assess how well it works in treating patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.

What is already known about the treatment

NVL-520 – NVL-520 is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. It is in the investigational stage, with ongoing research to determine its optimal dosing and therapeutic potential. The main therapeutic indication for NVL-520 is targeting ROS1-positive cancers, where it acts by selectively inhibiting the ROS1 protein, which is involved in the growth and spread of cancer cells. NVL-520 is classified as a targeted cancer therapy, specifically a ROS1 inhibitor, aiming to block the molecular pathways that contribute to tumor development.

Investigated diseases

  • Advanced ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

    This is a type of lung cancer characterized by the presence of a specific genetic alteration known as ROS1 rearrangement. It typically occurs in younger patients who are non-smokers or light smokers. The disease progresses as cancer cells grow and spread in the lungs and potentially to other parts of the body. Symptoms may include persistent cough, chest pain, and shortness of breath. As the disease advances, it can lead to more severe respiratory issues and general health decline. The presence of ROS1-positive tumors can influence the choice of targeted therapies.

  • Advanced ROS1-positive Solid Tumors

    These are a group of cancers that occur in various organs and tissues, characterized by the presence of ROS1 gene rearrangements. Such tumors can develop in different parts of the body, including the lungs, brain, and gastrointestinal tract. The disease progresses as the cancer cells multiply and invade surrounding tissues, potentially spreading to distant organs. Symptoms vary depending on the tumor's location but may include pain, swelling, or dysfunction of the affected organ. The ROS1-positive status of these tumors can guide specific treatment approaches. As the disease advances, it can lead to significant health challenges and complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-511793-71-00Protocol codeNVL-520-01Estimated enrolment600 patientsSponsorNuvalent Inc.

sourced from the EU Clinical Trials Register and site verification

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