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Study of Selpercatinib for Patients with Early-Stage RET Fusion-Positive Non-Small Cell Lung Cancer After Local Treatment

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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 RET fusion-positive non-small cell lung cancer (NSCLC). The treatment being tested is a medication called selpercatinib, which is a small molecule kinase inhibitor. This medication is taken orally in the form of a hard capsule. The study also involves a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the effectiveness of selpercatinib in patients who have early-stage RET fusion-positive NSCLC and have already undergone surgery or radiation treatment. Participants in the study will be randomly assigned to receive either selpercatinib or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will be monitored to assess the progression of their condition and any potential side effects of the treatment. The trial aims to provide valuable information on whether selpercatinib can improve outcomes for patients with this specific type of lung cancer. The study is expected to continue for several years to gather comprehensive data on the treatment's effectiveness and safety.

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. Participants must have early-stage non-small cell lung cancer (NSCLC) and have recovered from surgery or radiation. Good health is required, and effective birth control must be used during the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either selpercatinib or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    Selpercatinib is taken orally. The exact dosage and frequency are determined by the study protocol and are administered consistently throughout the trial period.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment. This includes tracking the event-free survival (EFS) of participants, which is assessed by investigators.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by August 14, 2032. Participants will be informed of their treatment group and the overall results of the study at the end of the trial.

Who can join the trial?

6 criteria

  • Participants must have early-stage **non-small cell lung cancer (NSCLC)**. This is a type of lung cancer that is in its initial stages.
  • Participants must have already had surgery or radiation and have recovered from it.
  • Participants must be in fair to good health, meaning they should generally feel well and not have serious health issues.
  • Participants must be willing to use highly effective birth control during the study to prevent pregnancy.
  • Both males and females can participate in the study.
  • The study includes people who might be considered vulnerable, meaning they may need extra care or protection.
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Investigated drugs

Selpercatinib is a medication being studied for its potential to help people with a specific type of lung cancer known as RET fusion-positive non-small cell lung cancer (NSCLC). This medication is being tested to see if it can improve the time patients live without their cancer getting worse after they have received their initial treatment. It is used in this study to see if it can prevent the cancer from returning or spreading.

What is already known about the treatment

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

Investigated diseases

RET fusion-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 RET fusion. It primarily affects the cells lining the lungs and is a subtype of non-small cell lung cancer, which is the most common form of lung cancer. The disease progresses as the cancerous cells grow and divide uncontrollably, potentially spreading to other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. The presence of RET fusion can influence the behavior of the cancer and its response to certain treatments. Understanding the genetic makeup of the cancer is crucial for determining the most effective treatment approach.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506784-33-00Protocol codeJ2G-MC-JZJXEstimated enrolment217 patientsSponsorEli Lilly & Co.

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