Considering the Harmony-Lung-1 clinical research trial?

If you have been recently diagnosed with non-small cell lung cancer (NSCLC), you are not alone in your medical journey. NSCLC is the most common type of lung cancer in the US, accounting for 84% of all lung cancer diagnoses.

Currently, we are developing potential new treatments for NSCLC. Harmony-Lung-1 is a clinical research trial that aims to test the safety and tolerability of an investigational combination of two medications to treat advanced NSCLC. Harmony-Lung-1 aims to see how effective the investigational combination is in comparison with one of the medications by itself. The trial will also look at how to better understand the study treatments and advanced NSCLC.

What is the study treatment?

One of the treatments is called “investigational” as it has not yet been approved to treat NSCLC. The other treatment has been approved by the U.S. Food & Drug Administration (FDA) and several other countries for the treatment of advanced NSCLC.

Investigational treatment:
The investigational treatment is a monoclonal antibody designed to block the action of a specific protein that may play a role in preventing immune cells from destroying cancer cells. Blocking this protein may help immune cells destroy cancer cells. Antibodies are proteins that are naturally found in your blood that fight infections, among other functions.

Approved treatment:
The approved treatment is also a monoclonal antibody designed to block the action of another protein that may also play a role in preventing immune cells from destroying cancer cells. Blocking this protein may help immune cells destroy cancer cells.

Placebo:
A placebo looks like the study treatment but does not contain any real medicine. Researchers can tell whether the study treatment is effective by understanding if it works better than a placebo.

This trial is divided into two parts. If you join the first part of the trial, you will be randomly (by chance) assigned to 1 of 3 treatment groups. If you join the second part of the trial, you will be randomly assigned to 1 of 2 treatment groups and will have an equal (50%) chance of being assigned to either group.

What can I expect if I join this trial?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the Harmony-Lung-1 trial. You may leave the trial at any time without it affecting your regular health care.

If you join the trial, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures including chest X-rays, imaging scans, biopsies, and blood draws. Your participation may last up to 5 years.

Qualified participants may be reimbursed for travel to and from study visits, and medical care related to their participation, including the study treatment, may be provided at no cost. The study team will discuss all of this with you.

How can I take part?

If you wish to take part in Harmony-Lung-1, you can fill in a short prescreener questionnaire to see if you may be eligible.

<span data-metadata=""><span data-buffer="">What else should I know?

As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to join, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.

There is no guarantee that you will receive a medical benefit from participating in this trial. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the trial for any reason and at any time.

Find a study site near you

To find out more about Harmony-Lung-1, and whether it may be right for you, please contact your closest study site – they will be more than happy to help. Find your nearest study site