Active not recruitingPHASE3INTERVENTIONAL

Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

This study is investigating a new drug called MEDI4736 for people who have had a specific type of lung cancer, known as non-small cell lung cancer (NSCLC), surgically removed. After surgery, and sometimes chemotherapy, some cancer cells can remain, potentially leading to the cancer returning. This trial aims to find out if taking MEDI4736 after your operation is more effective than not having any additional treatment in preventing the cancer's return. The study is "double-blind," meaning neither you nor your doctor will know if you are receiving the new drug or a placebo (an inactive substance), to ensure fair and accurate results. It's a Phase 3 study, which means it's testing the drug in a larger group of people after earlier studies showed promise.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Canadian Cancer Trials Group

Enrolment target

1,415

Start

24 Feb 2015

Estimated completion

31 Jan 2026

Non-Small Cell Lung Cancer

What is this study about?

This study is focused on a type of lung cancer called non-small cell lung cancer (NSCLC). When this cancer is diagnosed early, surgery is often used to remove the tumour. Sometimes, chemotherapy is also given afterwards to kill any remaining cancer cells. However, even with these treatments, there's a chance the cancer could come back.

Researchers are investigating a new drug called MEDI4736. They want to see if giving this drug after surgery (and possibly chemotherapy) can reduce the risk of the lung cancer returning. The study compares MEDI4736 against a 'placebo,' which looks like the drug but doesn't contain any active medicine. This helps researchers understand the true effect of MEDI4736.

By taking part, you would be helping doctors determine if MEDI4736 could become a new standard treatment option for people like you who have had NSCLC surgery. Discovering more effective ways to prevent cancer recurrence is crucial for improving long-term outcomes for patients.

Key takeaways

The study is for people who've had surgery for non-small cell lung cancer.
It compares a new drug, MEDI4736, with no further active treatment (placebo).
It's a 'double-blind' study, so you won't know if you're getting the drug or placebo.
You must have had all your cancer surgically removed.
The aim is to prevent the cancer from coming back.
You can stop participating at any time.

Who may be eligible?

To join this study, you must have been diagnosed with a specific type of lung cancer, non-small cell lung cancer, which has been completely removed by surgery. This means all visible cancer was taken out, and the edges of the removed tissue were clear of cancer cells. Your cancer must also be classified at certain stages (Stage IB, II, or IIIA). You cannot have had chemotherapy before your surgery, but you may have received standard chemotherapy after your operation.

You also need to be generally well and able to carry out your normal daily activities without too much difficulty. This is measured by something called an ECOG performance status of 0 or 1. There are also specific blood test results needed to ensure your body is healthy enough for the study. You must be at least 18 years old to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I had surgery for non-small cell lung cancer?
Was all of my cancer completely removed during surgery?
Was my lung cancer classified as Stage IB, II, or IIIA?
Have I had chemotherapy after my surgery, or no chemotherapy at all before surgery?
Am I at least 18 years old?
Am I generally well and able to manage most daily activities?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new drug MEDI4736 or a placebo (an inactive substance). Neither you nor your doctor would know which one you are receiving. You would need to attend regular clinic visits for check-ups, blood tests, and to receive your study medication. The total duration of your participation, including follow-up appointments, would be explained to you by the study team. They will also tell you about the frequency of visits and any tests involved. This is a journey with regular checks to monitor your health and the progress of the study.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health. However, there are also potential risks, including side effects from the study drug, which may or may not be known yet. You will be told about all known potential side effects. There is no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (271)

Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
USC Norris/Comprehensive Cancer Centre
Verified postcode
Los Angeles, United States
National Jewish Health
Verified postcode
Denver, United States
University of Florida
Verified postcode
Gainesville, United States
H. Lee Moffitt Cancer Center
Verified postcode
Tampa, United States
Duke University Medical Center
Verified postcode
Durham, United States
Hematology and Oncology Associates of NEPA
Verified postcode
Dunmore, United States
Thomas Jefferson University
Verified postcode
Philadelphia, United States
The Reading Hospital Medical Center
Verified postcode
West Reading, United States
Campbelltown Hospital
Verified postcode
Campbelltown, Australia
Chris O'Brien Lifehouse
Verified postcode
Camperdown, Australia
Coffs Habour Health Campus - NCCI
Verified postcode
Coffs Harbour, Australia

Common questions

What is a 'double-blind' study?

It means neither you nor your doctors will know if you're getting the new drug or a placebo (a dummy medicine) to make sure the results are fair.

What is a 'placebo'?

A placebo is a substance that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects.

Is MEDI4736 already approved for use?

No, it's an investigational drug, meaning it's still being studied to see if it's safe and effective before it can be approved.

Can I stop participating in the study if I change my mind?

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

Will I still receive my normal follow-up care for lung cancer?

Yes, participating in the study will be in addition to your standard care, and your doctors will continue to monitor your health.