About This Study | LIBRETTO-432 Lung Cancer Research Study

Non-Small Cell Lung Cancer (NSCLC) Research Study Enrolling Now

If you have been treated for NSCLC, you may qualify
for a research study to learn if an investigational
medication can help to prevent NSCLC from returning.

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Study Purpose

The purpose of the LIBRETTO-432 Study is to learn if an investigational drug can help prevent the return of non-small cell lung cancer (NSCLC) in people who have RET in their tumor. RET is an abnormal protein that can be responsible for cancer growth. You do not need to know if you have RET to be screened for this study. We will test you for RET during screening for free.

Currently, there are no drugs targeting RET to help prevent the return of NSCLC after it has been treated. Our study is researching an investigational drug that could help.

Key Details

Phase 3

This is a phase 3 research study. Phase 3 research studies are the third step in a four-step drug approval process. In this phase, scientists test whether an investigational medication is more effective than the standard treatment in people with a specific disease or condition.

Clinicaltrials.gov Study ID: NCT04819100

Highlights

When is the study enrolling participants?

Planned for 2021 - 2027

How many participants are required?

Approximately 170

Will I get the investigational drug?

Participants have:

50% chance of receiving Selpercatinib, the investigational drug
50% chance of receiving placebo

Those who receive a placebo could be eligible to receive Selpercatinib later. Read more about how placebos will be used in the Frequently Asked Questions section below.

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Who Qualifies?

You may qualify for this research study if you meet the criteria listed below. You can learn if you qualify after you indicate your interest in the study.

A history of stage IB, II, or IIIA non-small cell lung cancer

Have been treated for your non-small cell lung cancer

Age 18+

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Locations

Researchers in over 200 locations globally are looking for volunteers for this research study. The map below shows research sites currently open for enrollment in your region. New sites may be added at a later date, and it may be possible for you to travel to another location if there are no open sites within your state or country. You may also be reimbursed for travel or study-related expenses.

For more information, please click the I'm Interested button to be connected with a research site.

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Appointment Overview

Your appointments will take place for up to three years, and possibly longer, if you're receiving benefit. Each appointment is a little different. Some examples of common appointment activities are below. You will also take the study drug twice a day and fill out questionaries between appointments. Research study staff can tell you more.

Approximate Schedule

Participation Length

As long as you are receiving benefit

Appointments

About every 2 weeks

Appointment Time

3 hours average

Example Appointment Activities

Laboratory Tests

For example, hematology, chemistry panel, pregnancy tests, etc.

Vital Statistics

For example, weight, height, blood pressure, etc.

Imaging

For example, CT scans, MRIs, etc.

Next Steps To Participate

Once you click the I'm Interested button, the following steps are what you can expect to happen next. You can change your mind about participation at any time, even after you are enrolled.

Step 1

Prequalify for Research Study

Click the I’m Interested button and complete the prequalification steps online. You will answer questions about your eligibility and select a research site near you. Lastly, you will provide your contact information, which we will forward to the research site so they can contact you. You can also contact the research site with any questions before then, using the phone number provided in your confirmation email.

Step 2

Connect with Research Site

The research site study staff will contact you as soon as possible to tell you more about the study and to answer your questions. They will also ask you questions to further assess your eligibility for the research study. If you seem eligible to participate, a staff member will schedule a time for you to visit the research site.

Step 3

Visit Research Site

During your appointment, the research study staff will continue to assess your fit for the study. They will also give you important research study information, like the schedule of appointments and possible risks of participation. You will be able to ask questions too. The process of receiving important study information is called informed consent.

Step 4

Participate in Research Study

If you qualify, you can begin participating in the research study. To find out more about what's involved in participation, review the Appo intment Overview section. You can change your mind about being in the study at any point. You do not have to give a reason for leaving.

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Frequently Asked Questions

1. Will I receive a placebo?

Possibly.

This research study is using a placebo. A placebo is not the investigational medicine. It looks like the investigational medicine being studied but has no medicine.

You have a 50% chance of receiving a placebo and a 50% chance of receiving Selpercatinib, the investigational medicine. If you are in the placebo group, you may begin receiving Selpercatinib later in the study, depending on how you’re doing.

2. What is RET? Do I need to know my RET status to volunteer for this study?

RET is an abnormal protein that can be responsible for cancer growth. About 2% of people with non-small cell lung cancer have tumors where a piece of the RET gene is fused to part of another gene. This makes the cells produce abnormal RET proteins, which speeds up the growth of cancer cells. When this happens, the cancer is called RET fusion-positive.

Selpercatinib, the investigational medicine being tested in this study blocks the activity of RET proteins. It is a type of drug known as targeted therapy. Since the study is trying to learn if Selpercatinib can prevent the return of cancer in people with RET fusion-positive lung cancer, participants must have RET fusion-positive lung cancer to participate.

While your cancer needs to be RET fusion-positive to participate, you do not need to know your RET status to begin screening for the study. Research study staff will test you for RET and other genetic mutations associated with cancer growth. You will receive the testing for free during the screening process.

3. Do I need to have completed treatment to volunteer for this study?

You can begin the screening process during your treatment. If you meet the study eligibility criteria, and would like to participate, you can enroll and begin participating after you've completed your normal treatment.

4. What are some of the risks and benefits of participating in this research study?

Research studies are experimental in nature, so the risks and benefits can be difficult to predict. However, researchers only move forward with studies they believe might be beneficial to the participant, with acceptable risks. You will have the opportunity to discuss the risks and benefits in detail with the research staff before agreeing to participate.

Possible Benefits

Learn about your RET status and other genetic mutations your tumor may have
Possibly try an investigational drug for RET fusion-positive non-small cell lung cancer (NSCLC)
Close monitoring, care, and support from a research team of doctors and other healthcare professionals who understand your NSCLC
Take an active role in your healthcare
Could be part of the development of a possible new medication for NSCLC, possibly helping others like you

Possible Risks

Your lung cancer may return despite the treatments you have received
Possibly receiving a placebo
Side effects
Substantial time commitments during the research study

5. What happens if I stop participating in the research study?

Taking part in this research study is entirely up to you. You may refuse to take part in the research study, or you may stop your participation at any time.

Your participation also may be stopped by the research study doctor or other research study staff at any time, for any reason, without your consent. If this happens, it could be because of a bad reaction to the investigational medicine or new information about the investigational medicine's safety or effectiveness.

If you stop being part of this research study, the doctor or one of the research study staff members will talk to you about any medical issues that may happen from stopping your participation.

6. What are the costs of taking part in this research study?

There is no cost to participate in this research study. LOXO Oncology at Lilly (Eli Lilly and Company), the research study's sponsor, is covering the costs of appointments, lab tests, and the investigational medicines related to the study at no cost to you.

You may be reimbursed for travel or study-related expenses. For more information, please click the I'm Interested button to be connected with a research site.

7. What are my rights as a research study participant?

You have the right to drop out at any time.
- You don't have to give a reason for leaving.
You have the right to not participate in the research study.
- Even if you have made it through screening and are "approved" to participate in the research study, you do not have to participate. If you decided to participate you can still change your mind at any time and leave the study. You do not have to give a reason for leaving.
You have the right to be given more information about the study.
- Informed consent is an ongoing process. You will be informed of any changes throughout the study.
You have the right to ask questions at any time.
- You can ask questions about anything you don't understand, or even just want to know at any time.

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Are You Interested?

If you're interested in trying something new for your non-small cell lung cancer, you may be interested in our clinical trial.

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About Lung Cancer Research

Have you wondered how lung cancer medicines end up being available to you and others with non-small cell lung cancer? If you're interested in learning more about this, we have an entire page devoted to lung cancer research and study participation.

About Lung Cancer Research