Considering the Harmony Peri-Operative Lung clinical research study?

If you have been recently diagnosed with non-small cell lung cancer (NSCLC), please know that you are not alone in your medical journey. NSCLC is one of the most common types of lung cancer in the US, accounting for 84% of all lung cancer diagnoses, with 75% of these cases diagnosed in advanced stage.

Currently, we are working on developing potential treatments for resectable (operable, meaning tumors can be removed by surgery) NSCLC at stage II to IIIB (N2). Harmony Peri-Operative Lung is a phase 2 clinical study that aims to assess the efficacy (effectiveness), safety, and tolerability of the combination of 2 investigational study drugs and chemotherapy in comparison with 1 of the study drugs and chemotherapy as therapy in combination with surgery in patients with NSCLC.

If you are eligible, you will undergo peri-operative therapy (treatment both before [known as neoadjuvant therapy] and after [known as adjuvant therapy] surgical removal of the lung cancer).

What is the study treatment?

The first study drug is called “investigational” as it has not yet been approved to treat NSCLC. The second study drug has been approved by the U.S. Food & Drug Administration (FDA) and several other countries for the treatment of advanced NSCLC under certain conditions. It is considered investigational in this study because it has not been approved for the treatment of NSCLC following surgery and has not been approved for use in combination with the first study drug.

Study drug 1:  
This investigational treatment is a monoclonal antibody designed to block the action of a protein called lymphocyte activation gene 3 (LAG-3).

Study drug 2:  
This investigational treatment is a monoclonal antibody that blocks the programmed death receptor 1 (PD-1), a cell receptor on immune cells. LAG-3 and PD-1 may both play a role in preventing immune cells from destroying cancer cells. Blocking LAG-3 and/or PD-1 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.

Once the study doctor confirms that you qualify, you will be randomly (by chance) assigned to 1 of 3 treatment groups. You will either receive a combination of the investigation study drugs or the second investigational study drug plus a placebo. You will be given doses of the treatments into a vein using a needle. This is called an IV infusion.

In the neoadjuvant period (before surgery), in addition to one of the above treatments, you will also receive chemotherapy every 3 weeks. After surgical removal of your tumor, the study doctor will determine if all or most of the tumor was successfully removed. If not, you may not be able to proceed to the adjuvant treatment period, and your disease would be treated per local guidelines.

This trial is double-blind. This means that neither you nor the study doctor or the staff will know which treatment you are receiving. The study doctor or staff can be told what you received if there is an emergency.

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 Peri-Operative Lung study. You may leave the study at any time without it affecting your regular health care.

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

There will be no cost to you for the study drugs, visits, tests, or supplies that are required for the study. Reasonable travel costs (like fuel and bus/train tickets) and food costs may be refunded to you. You or your health insurance will also have to pay for medications, tests, and supplies that are not required as part of the study.

How can I take part?

If you wish to take part in Harmony Peri-Operative Lung, you can fill in a short pre-screener questionnaire to see if you may be eligible.

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 study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Find a study site near you

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