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Study Comparing Selpercatinib with a Drug Combination for Patients with Advanced RET Fusion-Positive Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo
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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 Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer. The study aims to compare the effectiveness of a new treatment called Selpercatinib with a combination of existing treatments. These existing treatments include Platinum-Based therapies such as Carboplatin or Cisplatin, Pemetrexed, and Pembrolizumab. The purpose of the study is to see how well Selpercatinib works compared to these other treatments in patients with this specific type of lung cancer.

Participants in the study will receive either Selpercatinib or a combination of the other treatments. The study will monitor the progress of the disease and how the treatments affect it. The treatments will be given through different methods, such as infusion, which is a way of delivering medicine directly into the bloodstream, or oral use, which involves taking medicine by mouth. The study will take place over a period of time, and participants will be closely observed to understand the effects of the treatments.

The study is designed to provide valuable information about the potential benefits of Selpercatinib for patients with RET Fusion-Positive Non-Small Cell Lung Cancer. By comparing it with existing treatments, researchers hope to find the most effective way to manage this type of cancer. The results of this study could lead to improved treatment options for patients in the future.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying the presence of advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic feature called RET fusion.

    Participants must have sufficient tumor tissue available for confirmatory testing and be in fair to good health without other serious medical conditions.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two treatment groups. One group receives selpercatinib, and the other group receives a combination of platinum-based therapy (either carboplatin or cisplatin), pemetrexed, and possibly pembrolizumab.

  3. Step 3

    Selpercatinib administration

    For those in the selpercatinib group, the medication is taken orally. The specific dosage and frequency are determined by the study protocol and the participant's health status.

  4. Step 4

    Platinum-based therapy administration

    Participants in the platinum-based therapy group receive carboplatin or cisplatin through infusion. The dosage and frequency are based on the study protocol.

  5. Step 5

    Pemetrexed administration

    Pemetrexed is administered via infusion to participants in the platinum-based therapy group. The schedule is determined by the study protocol.

  6. Step 6

    Pembrolizumab administration

    If assigned, pembrolizumab is given through infusion. The decision to include pembrolizumab is based on the study protocol.

  7. Step 7

    Monitoring and follow-up

    Throughout the trial, participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects. This includes medical examinations and imaging tests.

    The trial aims to compare the progression-free survival (PFS) of participants receiving selpercatinib with those receiving the combination therapy.

  8. Step 8

    Trial completion

    The trial is expected to conclude by June 18, 2026. Participants will be informed of the results and any further steps after the trial ends.

Who can join the trial?

7 criteria

  • Participants must have **advanced or metastatic** non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation therapy. **Advanced or metastatic** means the cancer has spread to other parts of the body.
  • Participants must have a **RET gene fusion** and enough tumor tissue available for confirmatory testing. A **RET gene fusion** is a specific change in the cancer cells that can be tested.
  • Participants must be in fair to good health and not have another serious medical condition.
  • Participants must not have had prior chemotherapy for metastatic lung cancer. Chemotherapy given after surgery (adjuvant) or before surgery (neoadjuvant) is allowed.
  • Participants must not have disease that has spread to the brain and is causing symptoms.
  • Participants must be able to swallow capsules.
  • Participants must be willing to use highly effective contraception during the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have **advanced or metastatic RET fusion-positive non-small cell lung cancer**. This means the cancer must have spread to other parts of the body and have a specific genetic change called RET fusion.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Selpercatinib

    is a medication being studied for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change known as RET fusion. It works by targeting and blocking the activity of proteins that help cancer cells grow.

  • Carboplatin

    is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.

  • Cisplatin

    is another chemotherapy medication similar to carboplatin. It is used to treat different cancers by interfering with the DNA in cancer cells, stopping them from multiplying.

  • Pemetrexed

    is a chemotherapy drug that is often used in combination with other medications to treat lung cancer. It works by blocking the cancer cells' ability to use folate, a vitamin that is necessary for their growth.

  • Pembrolizumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to treat various types of cancer, including lung cancer, by blocking a protein that prevents the immune system from attacking cancer cells.

What is already known about the treatment

Selpercatinib – Selpercatinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC). It is a targeted therapy that works by inhibiting the activity of the RET protein, which can drive cancer cell growth when mutated. Selpercatinib is classified as a kinase inhibitor and is being compared to traditional chemotherapy regimens in ongoing research to determine its potential benefits in cancer treatment.

Investigated diseases

Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as RET fusion. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. The disease is considered advanced or metastatic when it has spread beyond the lungs to other parts of the body. RET fusion-positive indicates that the cancer cells have a rearrangement in the RET gene, which can drive cancer growth. This genetic change can make the cancer more aggressive and influence how it progresses. The progression of this disease can vary, but it often involves the growth and spread of cancerous cells to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506783-14-00Protocol codeJ2G-MC-JZJCEstimated enrolment132 patientsSponsorEli Lilly & Co.

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