Active not recruitingPHASE3INTERVENTIONAL

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

This research study, called RELAY, is for people with advanced non-small cell lung cancer that has a specific genetic change (EGFR mutation). The main part of the study compares a new treatment combining ramucirumab with erlotinib, to a placebo (dummy drug) also with erlotinib. This helps scientists understand if adding ramucirumab improves treatment effectiveness and safety. There's also a part of the study, mainly for people in East Asia, looking at ramucirumab with gefitinib. Another section explores ramucirumab with osimertinib for those whose cancer has progressed. The goal is to find better treatment options for this type of lung cancer by carefully checking how well these drug combinations work and if they are safe.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

545

Start

06 May 2015

Estimated completion

01 Dec 2026

Metastatic Non-Small Cell Lung Cancer

What is this study about?

This research study, known as RELAY, is looking for better ways to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC). This cancer has spread (metastatic) and contains a particular genetic change, known as an EGFR mutation (specifically, exon 19 deletion or L858R substitution in exon 21). These mutations mean the cancer might respond to certain targeted therapies, but there's always a search for more effective and safer treatments.

The main part of the study compares two groups of people who are starting treatment for the first time. One group receives a drug called ramucirumab along with erlotinib, which is a standard treatment. The other group receives a 'placebo' (a dummy drug that looks like ramucirumab but contains no active medicine) also with erlotinib. This comparison helps researchers understand if adding ramucirumab improves how long the treatment works and how safe it is overall. Before the main comparison, a smaller group of people will first receive ramucirumab with erlotinib to check its initial safety.

There are also other parts to the study. One part specifically examines ramucirumab combined with gefitinib for people from East Asia with this same type of lung cancer. Another part looks at ramucirumab with osimertinib for people whose cancer has progressed after initially receiving ramucirumab and gefitinib, and whose cancer has developed another specific genetic change called a T790M mutation. The overall goal of RELAY is to gather important information about these drug combinations to potentially offer more effective options for people living with this type of lung cancer.

Key takeaways

This study evaluates new drug combinations for advanced non-small cell lung cancer with an EGFR mutation.
It compares ramucirumab plus erlotinib against a placebo plus erlotinib.
Other parts explore ramucirumab with gefitinib or osimertinib in specific situations.
Participation involves regular clinic visits, medication, and monitoring.
The goal is to find more effective and safer treatments for this type of cancer.

Who may be eligible?

To be considered for this study, you would need to have non-small cell lung cancer that has spread (stage IV) and has been confirmed by a doctor. Importantly, your cancer must also have a specific genetic change called an EGFR mutation (either an exon 19 deletion or an L858R mutation in exon 21). This means your doctor believes you would be a good candidate for first-line treatment with erlotinib. You should also have at least one measurable area of cancer that doctors can track.

There are also some reasons why you might not be able to join the study. For example, if you already have a different EGFR mutation called T790M, or if the cancer has spread to the fluid around your brain or spinal cord. Certain other serious medical conditions, ongoing medications, or a history of significant bleeding problems would also prevent you from participating. Your doctor will carefully check all these details to see if this study is suitable for you.

Quick self-check

Do I have advanced non-small cell lung cancer that has spread?
Has my cancer been tested and confirmed to have an EGFR exon 19 deletion or L858R mutation?
Am I generally well enough to start a new treatment plan?
Do I have any significant bleeding problems or heart conditions?
Am I currently taking any medications that might interfere with study drugs?

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

What does participation involve?

This study involves taking medication and having regular check-ups. You would typically take tablets by mouth every day as prescribed by the study doctors. You'll have regular visits to the clinic for assessments, which will include blood tests, physical examinations, and scans (like CT scans) to monitor your cancer and check for any side effects. You might also need to provide tissue samples for analysis.

The total duration of your participation in the study is not fixed, as it depends on how well the treatment works for you and how you tolerate it. You will continue treatment as long as it is benefiting you and any side effects are manageable. After you stop taking the study medication, there will be a follow-up period where the study team will continue to monitor your health and well-being. Exactly how often you'll visit the clinic and for how long you'll be followed up will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new and possibly more effective treatment for your cancer, or receiving closer medical monitoring than currently available. However, there are no guarantees that the treatment will work for you. Like all medications, the trial drugs can cause side effects, which could range from mild to serious. These risks will be fully explained to you before you decide to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (106)

UCLA Hematology/Oncology - Santa Monica
Los Angeles, United States
St. Charles Health System
Denver, United States
The Gastroenterology Group, P.C.
Honolulu, United States
Cancer Center of Kansas
Wichita, United States
Queens Medical Associates
Fresh Meadows, United States
Levine Cancer Institute
Charlotte, United States
AHN Allegheny General Hospital
Pittsburgh, United States
Cross Cancer Institute
Edmonton, Canada
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France
Chu Grenoble Alpes
La Tronche, France
Hopital Claude Huriez - CHU de Lille
Lille, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France

+94 more sites — see the official record for the full list.

Common questions

What is EGFR mutation-positive lung cancer?

It's a type of non-small cell lung cancer with a specific genetic change (mutation) that can make it more responsive to certain targeted treatments.

What is ramucirumab?

Ramucirumab is a drug that aims to stop cancer growth by preventing it from forming new blood vessels it needs to survive.

What does 'placebo' mean?

A placebo is a dummy treatment that looks exactly like the real drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

How long would I be in the study?

You would stay in the study as long as the treatment is helping you and you are tolerating it well. There's also a follow-up period after you stop treatment.

Will I know if I'm getting the new drug or the placebo?

No, in the main part of the study, neither you nor your doctors will know whether you are receiving ramucirumab or the placebo. This is called 'blinded' to ensure fair results.