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Study Comparing Pralsetinib and Standard Drug Combination for Patients with Advanced RET Fusion-Positive Non-Small Cell Lung Cancer

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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 lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called RET fusion. The study is comparing a new treatment called Pralsetinib with standard treatments that include various chemotherapy drugs. These standard treatments may involve medications such as Pemetrexed, Carboplatin, Cisplatin, Gemcitabine, Paclitaxel, and Pembrolizumab. The purpose of the study is to see if Pralsetinib can help patients live longer without their cancer getting worse compared to the usual treatments.

Participants in the study will be randomly assigned to receive either Pralsetinib or one of the standard chemotherapy treatments. The study will monitor the participants over time to see how their cancer responds to the treatment. This includes checking if the cancer shrinks, stays the same, or grows. The study will also look at how long participants live and any side effects they experience. The treatment period can vary, with some treatments lasting up to 104 weeks.

The study is open-label, meaning both the participants and the researchers know which treatment is being given. Participants will receive their treatment through different methods, such as IV infusion or taking capsules orally, depending on the medication. The study aims to provide valuable information on the effectiveness and safety of Pralsetinib compared to the standard care options for patients with this specific type of lung 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 participant is confirmed to have advanced non-small cell lung cancer (NSCLC) that is either stage IIIB or stage IV and has not been treated with systemic anticancer therapy for metastatic disease.

    The participant must have a documented RET fusion, which is a specific genetic alteration, confirmed by a certified laboratory.

  2. Step 2

    Randomization

    The participant is randomly assigned to one of two groups: one receiving the investigational drug pralsetinib or the other receiving a standard treatment regimen containing platinum-based drugs.

  3. Step 3

    Treatment administration

    Participants in the pralsetinib group take the medication orally. The dosage and frequency are determined by the study protocol.

    Participants in the standard treatment group receive medications such as pemetrexed, carboplatin, cisplatin, paclitaxel, paclitaxel albumin-bound, pembrolizumab, or gemcitabine through intravenous infusion or injection, depending on the specific drug.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects. This includes imaging tests to evaluate tumor response and regular health check-ups.

    The primary goal is to measure progression-free survival, which is the time during and after treatment that the participant lives with the disease without it getting worse.

  5. Step 5

    Completion of treatment

    The treatment continues until the disease progresses, unacceptable side effects occur, or the participant decides to withdraw from the study.

    The study is estimated to conclude by May 31, 2025.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of advanced **Non-Small Cell Lung Cancer (NSCLC)** that cannot be removed by surgery or has spread to other parts of the body. This includes both squamous and non-squamous types of NSCLC.
  • The patient must have a **RET fusion**, which is a specific genetic change in the cancer. This must be confirmed by a certified laboratory using tissue or blood samples.
  • The patient must have cancer that can be measured by doctors using a standard method called **RECIST 1.1**. If the cancer was treated with radiation before, it must have grown again to be considered measurable.
  • The patient must have an **ECOG Performance Status** of 0-1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must test negative for **HIV** at the start of the study. If they are HIV positive, they must be stable on treatment, have a certain level of immune cells (CD4 count ≥ 200/µL), and have no detectable virus in their blood.
  • The patient must not have received any previous treatment for cancer that has spread. They can have had treatment before if it was not for the spread of cancer and if it was completed at least 6 months before the cancer came back.
  • Both male and female patients can participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who do not have **RET fusion-positive** cancer. This means the cancer cells have a specific change in their genes.
  • Patients whose cancer is not **metastatic**. This means the cancer has not spread to other parts of the body.
  • Patients who do not have **Non-Small Cell Lung Cancer**. This is a type of lung cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medication or similar drugs.
  • Patients who are not willing or able to provide informed consent, which means agreeing to participate after understanding the study details.
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Investigated drugs

  • Pralsetinib

    is a medication being studied for its effectiveness in treating a specific type of lung cancer known as RET fusion-positive metastatic non-small cell lung cancer (NSCLC). This medication is being compared to standard treatments to see if it can help patients live longer without their cancer getting worse.

  • Standard of Care

    refers to the usual treatment options that doctors typically use for this type of lung cancer. In this study, it includes various anticancer treatments that contain platinum, which is a common component in chemotherapy regimens. The goal is to determine if pralsetinib offers any advantages over these standard treatments.

What is already known about the treatment

Pralsetinib – Pralsetinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating RET fusion-positive, metastatic non-small cell lung cancer (NSCLC). The main therapeutic indication for pralsetinib is to improve progression-free survival in patients with this specific type of lung cancer. At the molecular level, pralsetinib works by selectively inhibiting the RET kinase, which is involved in the growth and spread of cancer cells. It is classified pharmacologically as a tyrosine kinase inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease often progresses slowly compared to small cell lung cancer, and symptoms may include persistent cough, chest pain, and shortness of breath. In some cases, the cancer can spread to other parts of the body, a process known as metastasis. RET fusion-positive refers to a specific genetic alteration found in some cases of this cancer, which can influence the behavior and treatment response of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505035-12-00Protocol codeBO42864Estimated enrolment233 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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