Active not recruitingPHASE3INTERVENTIONAL

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

This research study is looking at a drug called selpercatinib. The main goal is to find out if this medicine can safely and effectively delay a return of non-small cell lung cancer (NSCLC) in patients who have already had surgery or radiation treatment for their early-stage cancer. We want to see if selpercatinib works better than a dummy pill (placebo). If you are on the dummy pill and your cancer unfortunately comes back, you might then have the option to switch to taking selpercatinib. Taking part in this study could last up to three years. The study focuses on a specific type of NSCLC with a particular genetic change in the cancer cells.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

152

Start

20 Dec 2021

Estimated completion

01 May 2028

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is about an important type of lung cancer called non-small cell lung cancer (NSCLC). If you've recently had surgery or radiation therapy for early-stage NSCLC, this study might be relevant to you. The main purpose is to explore if a new medication, selpercatinib, can help prevent the cancer from returning and improve outcomes after your initial treatment.

We know that some lung cancers have specific changes in their genes that can make them grow. This study is for people whose cancer cells have a particular genetic change called a 'RET gene fusion'. The study will compare selpercatinib to a placebo, which looks like the study drug but contains no active medicine. This comparison helps researchers understand if selpercatinib is genuinely effective and safe. By participating, you could be helping to find better treatments for future patients with this type of lung cancer.

Your participation would help doctors learn more about this drug and its potential benefits for people with NSCLC. It's important to remember that joining a study like this is a big decision, and you'll have a study team to support you and answer all your questions.

Key takeaways

This study is for early-stage non-small cell lung cancer (NSCLC).
Your cancer must have a specific 'RET gene fusion'.
You must have already had surgery or radiation therapy.
It tests a drug called selpercatinib against a dummy pill (placebo).
The goal is to see if the drug can stop cancer from returning.
Participation could last up to three years.

Who may be eligible?

To join this study, doctors need to confirm that your non-small cell lung cancer (NSCLC) is at an early stage (Stage IB, II, or IIIA). A very important point is that your cancer cells must have a specific genetic change called a 'RET gene fusion'. This will be checked using a special test on your tumour.

Also, you must have already had surgery or radiation therapy to try and cure your lung cancer. The study team will also need to make sure you are generally well enough to take part, based on things like your overall health, blood test results (for your liver, kidneys, and blood), and your heart health. If you are having chemotherapy or another treatment called durvalumab after your main surgery/radiation, there are specific timeframes for when you can start this study after finishing those treatments.

There are also reasons why you wouldn't be able to join. For example, if tests show other specific gene changes in your cancer, if you have certain heart problems, severe infections, or other serious health issues that could make the study medicine unsafe for you. We also can't include people whose cancer has already come back or progressed after their initial treatment.

Quick self-check

Do I have non-small cell lung cancer (NSCLC) at an early stage (IB, II, or IIIA)?
Has my doctor confirmed my cancer has a 'RET gene fusion'?
Have I already had surgery or radiation therapy for my lung cancer?
Am I generally well, and do my blood tests (for liver, kidneys) look good?
Am I able to use effective birth control if I could have children?
Do I have certain heart conditions or other serious illnesses that might prevent me from joining?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be assigned by chance to receive either the study drug, selpercatinib, or a dummy pill (placebo). This is like flipping a coin to ensure a fair comparison. You would take your assigned medication regularly. You'd have regular check-ups, appointments with the study team, and tests, which might include blood tests and scans, to monitor your health and how the treatment is working.

The study also includes what's called a 'crossover' option: if you're on the dummy pill and your cancer unfortunately comes back or gets worse, you might then have the option to switch to taking selpercatinib. The total time you could be involved in this study, including follow-up, could be up to three years.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining access to a new experimental treatment that might help prevent your cancer from returning. You'll also receive close medical attention and monitoring from a dedicated study team. However, there are also potential risks; selpercatinib, like all medicines, can have side effects, and some may be serious. The study team will explain these in detail. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (211)

UCLA Hematology/Oncology - Santa Monica
Los Angeles, United States
Stockton Hematology Oncology Group
Stockton, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, United States
GenesisCare
Aventura, United States
GenesisCare - Boca Raton
Boca Raton, United States
USO-Cancer Care Center of Brevard, Inc.
Palm Bay, United States
Dana-Farber Cancer Institute
Boston, United States
Mayo Clinic in Rochester, Minnesota
Rochester, United States
USO-New York Oncology Hematology, P.C
Latham, United States
Memorial Sloan Kettering Cancer Center
New York, United States
USO - Alliance Cancer Specialists, PC
Horsham, United States
Sarah Cannon Research Institute SCRI
Nashville, United States

+199 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer, and people in this study have an early stage of it.

What is a 'RET gene fusion'?

It's a specific genetic change in some cancer cells that can help them grow. This study is only for people whose cancer has this change.

What does 'placebo' mean?

It's a dummy pill that looks like the real medicine but contains no active drug. It helps us see if the drug is actually working.

How long will I be in the study?

Your involvement could last up to three years, including check-ups and taking the study medicine.

Can I stop being in the study if I want to?

Yes, you can leave the study at any time, and it won't affect your future medical care.