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Study of NVL-655 for Patients with Advanced Non-Small Cell Lung Cancer and Other Solid Tumors with ALK Mutation

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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 medication called NVL-655, which is being tested for its effects on certain types of cancer. The diseases being studied include advanced Non-Small Cell Lung Cancer (NSCLC) and other solid tumors that have a specific change in their genes known as an ALK rearrangement or an activating ALK mutation. These changes can cause cancer cells to grow and spread.

The purpose of the study is to evaluate the safety and effectiveness of NVL-655 in patients with these types of cancers. The study is divided into two phases. In the first phase, the focus is on understanding how safe the medication is and how well patients can tolerate it. This phase also aims to find the right dose of the medication. In the second phase, the study will look at how effective NVL-655 is in treating patients with advanced ALK-positive cancers, including those who have developed resistance to other treatments.

Participants in the study will take NVL-655 in the form of a tablet, which is taken by mouth. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The study will monitor participants over time to assess the medication's impact on their cancer and any side effects they may experience. The goal is to gather information that could lead to new treatment options for patients with these challenging 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, the patient will be informed about the trial's purpose and procedures. The study focuses on the medication NVL-655, which is an oral tablet designed to treat advanced non-small cell lung cancer (NSCLC) and other solid tumors with specific genetic changes.

    The patient will be required to provide consent to participate in the study, acknowledging understanding of the trial's objectives and potential risks.

  2. Step 2

    Phase 1: safety and dosage evaluation

    During this phase, the patient will receive NVL-655 tablets orally. The main goal is to assess the safety and tolerability of the medication. The dosage will be adjusted to determine the recommended phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD).

    The patient will undergo regular health assessments, including laboratory tests, to monitor any side effects and changes in health status.

  3. Step 3

    Phase 2: efficacy evaluation

    In this phase, the patient will continue to take NVL-655 at the determined RP2D. The focus will be on evaluating the effectiveness of the medication in treating the cancer, particularly in patients with advanced ALK-positive NSCLC and other solid tumors.

    The patient's response to the treatment will be measured using imaging tests to assess tumor size and progression.

  4. Step 4

    Ongoing monitoring and assessments

    Throughout the trial, the patient will have regular appointments for health monitoring. This includes checking for any side effects, evaluating the medication's impact on the cancer, and adjusting treatment as necessary.

    The patient will be asked to report any new symptoms or changes in health to the study team promptly.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by March 31, 2026. Upon completion, the patient will have a final assessment to evaluate the overall impact of the treatment.

    The results from the trial will contribute to understanding the safety and effectiveness of NVL-655 for treating specific types of cancer.

Who can join the trial?

8 criteria

  • Must be at least 18 years old. For a specific group in Phase 2, must be at least 12 years old and weigh more than 40 kg.
  • Must have a type of cancer called a solid tumor that is either locally advanced or has spread to other parts of the body. This tumor must have a specific change in the ALK gene, known as an ALK rearrangement or activating ALK mutation.
  • For Phase 1, the cancer must be confirmed through tests called histology or cytology, which examine cells or tissues under a microscope.
  • For certain groups in Phase 2, the cancer must also be confirmed through histology or cytology and have the ALK gene change.
  • For another specific group in Phase 2, the cancer must be a solid tumor, including a type called Non-Small Cell Lung Cancer (NSCLC), and have the ALK gene change.
  • For Phase 1, the cancer must be able to be evaluated using a method called RECIST 1.1, which is a set of rules to measure how the cancer responds to treatment.
  • For Phase 2, the cancer must have at least one area that can be measured using RECIST 1.1.
  • Must provide a sample of the tumor tissue before starting the trial.
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Investigated drugs

NVL-655 is a medication being studied for its potential to treat patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. It works by selectively inhibiting a protein called anaplastic lymphoma kinase (ALK), which can be involved in the growth of cancer cells. The trial aims to assess the safety and tolerability of NVL-655, as well as its effectiveness in treating tumors that are positive for ALK, including those that have developed resistance to other treatments.

What is already known about the treatment

NVL-655 – NVL-655 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in treating advanced non-small cell lung cancer (NSCLC) and other solid tumors with ALK rearrangement or activating ALK mutation. It is in the early phases of clinical research, focusing on its safety, tolerability, and effectiveness. The main therapeutic indication is for patients with ALK-positive solid tumors, including those with resistance mutations. NVL-655 works by selectively inhibiting the anaplastic lymphoma kinase (ALK) at the molecular level, which is crucial for the growth and survival of certain cancer cells. It is classified pharmacologically as an ALK inhibitor.

Investigated diseases

  • Advanced Non-Small Cell Lung Cancer (NSCLC)

    This is a type of lung cancer that is more common and generally grows and spreads more slowly than small cell lung cancer. It begins in the tissues of the lungs and can spread to other parts of the body. The disease is characterized by the presence of abnormal cells that form tumors in the lung tissue. As it progresses, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The disease may also lead to weight loss and fatigue as it advances. It is often associated with genetic mutations, such as ALK rearrangement, which can influence its behavior and progression.

  • Solid Tumors with ALK Rearrangement or Activating ALK Mutation

    These are a group of cancers that occur in various organs and are characterized by the presence of a specific genetic alteration known as ALK rearrangement or mutation. This genetic change can lead to uncontrolled cell growth and tumor formation. Solid tumors can develop in different parts of the body, including the lungs, brain, and other organs. The presence of ALK mutations can affect how the tumor grows and responds to certain treatments. Symptoms and progression can vary depending on the tumor's location and size. These tumors are often studied for their unique genetic characteristics and potential targeted therapies.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-514266-39-00Protocol codeNVL-655-01Estimated enrolment716 patientsSponsorNuvalent Inc.

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