Active not recruitingPHASE2INTERVENTIONAL

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC

This study is for people with a specific type of lung cancer (non-small cell lung cancer) that can be removed with surgery. Researchers are testing new drug combinations given before the operation. One combination is nivolumab alone, another is nivolumab with ipilimumab, and a third is nivolumab combined with standard chemotherapy. The main goals are to find out if these treatments are safe, how well people tolerate them, and if they help shrink the tumour before surgery. The study also wants to understand more about how these drugs affect the body’s immune system to fight cancer, which could help plan future cancer treatments. It’s a Phase 2 study, meaning it’s an early stage to check safety and initial effectiveness.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrolment target

Start

01 Sep 2014

Estimated completion

01 Oct 2027

Non-Small Cell Lung Cancer

Results

Results from this study

Posted March 2024

Results have been published for this study.

Primary outcome

Safety as Measured by Number of Participants With Grade 3 and 4 Lab Abnormalities, as Defined by CTCAE v4.03

Safety will be measured by drawing safety labs. (CBC and a Chemistry Panel will be drawn at 2 week intervals during Nivolumab administration). Grade 3 and 4 lab abnormalities will be recorded from both participating sites.

Full results on the registry

What is this study about?

This research study is about finding better ways to treat a common type of lung cancer called non-small cell lung cancer. In this study, doctors are looking at new treatments given *before* surgery for patients whose cancer can be taken out by an operation. Doctors want to see if giving these treatments earlier can improve outcomes. The treatments being tested are drugs called nivolumab, which might be given by itself, or with another drug called ipilimumab. There's also a group that will receive nivolumab along with standard chemotherapy drugs.

These drugs are a type of treatment called immunotherapy, which helps your body's own immune system fight cancer. The researchers want to find out if these pre-surgery treatments are safe and how well people tolerate them. They are also keen to understand how these drugs affect the patient's body and the cancer itself, including how the immune system responds. This information is really important because it helps doctors plan future studies and decide which patients might benefit most from these new ways of treating lung cancer.

The ultimate goal of this research is to find more effective treatments for lung cancer and to understand who will benefit most from them, while also trying to reduce side effects for those who might not benefit. By learning more about these combinations now, doctors hope to offer better choices for people with non-small cell lung cancer in the future.

Key takeaways

New treatments (nivolumab, alone or with other drugs) are being tested for lung cancer before surgery.
The study aims to see if these treatments are safe and if they help fight the cancer earlier.
It's a Phase 2 study, meaning it's an early stage to check for safety and initial promise.
Immunotherapy is a main focus, aiming to boost your body's immune response against cancer.
Participants need to be well enough for treatment and potential surgery, with normal organ function.
The findings could help improve future lung cancer care and identify who benefits most.

Who may be eligible?

To join this study, doctors need to confirm that you have non-small cell lung cancer based on a tissue sample (biopsy). This cancer must be at a stage where it can potentially be removed by surgery, but it's considered high-risk. Your doctors will decide if your cancer fits these criteria, paying close attention to the size and spread of the cancer.

You also need to be generally well enough to take part. This means your body, including your heart, lungs, and other organs, should be working properly. Doctors will do tests to check your blood cell counts, kidney and liver function, and make sure your lungs are healthy enough for surgery, if needed. You should also be able to carry out your daily activities without too much difficulty.

The study is open to both men and women aged 18 and over. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to agree to use effective birth control during the study and for some time afterwards, as the effects of these drugs on a developing baby are unknown.

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.

Do you have non-small cell lung cancer that doctors think can be surgically removed?
Is your cancer considered high-risk?
Are you 18 years old or older?
Are you generally well and able to manage daily activities without much trouble?
Are your major organs (like kidneys, liver, lungs) working within a healthy range?
Are you willing to use effective birth control if you are of childbearing potential?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a number of tests to check if you are eligible. If you are, you would receive the study medication (either nivolumab alone, nivolumab plus ipilimumab, or nivolumab plus chemotherapy) before your surgery. These drugs are usually given through a drip into your vein. The number and timing of these treatments would be carefully scheduled by the study team.

You would have regular visits to the clinic for blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting the cancer. After the pre-surgery treatment, you would have your planned surgery. Following surgery, the study team would continue to monitor your health and recovery, and take further samples to understand the treatment's effect. The total duration involves the treatment period before surgery, the surgery itself, and then follow-up appointments to track your progress and any long-term effects.

Potential risks and benefits

Potential benefits of taking part in this study include receiving new treatments that might help shrink your cancer before surgery, which could lead to a better outcome. You would also be closely monitored by a team of doctors. However, there are also potential risks, as these are new combinations of drugs and can cause side effects. These can range from mild (like tiredness or skin rashes) to more serious problems that might affect your organs. The study team will explain all known side effects. Being part of a study like this means helping doctors learn more, which could benefit future patients. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Johns Hopkins at Bayview Medical Center
Verified postcode
Baltimore, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verified postcode
Baltimore, United States
Memorial Sloan Kettering
Verified postcode
New York, United States
Swedish Cancer Insitute
Verified postcode
Edmonds, United States
Johnathan Spicer
Verified postcode
Montreal, Canada

Common questions

What is 'immunotherapy'?

Immunotherapy is a type of treatment that uses your body's own immune system to find and fight cancer cells. It's different from chemotherapy, which directly kills cancer cells.

What does 'before surgery' (neoadjuvant) mean?

It means the treatment is given before you have your operation. The aim is often to shrink the tumour or make the surgery more effective.

Are the treatments in this study standard care?

No, these are experimental combinations of drugs that are not yet standard treatment for lung cancer before surgery. They are being studied to see if they are safe and effective in this setting.

Will I know which treatment I'm getting?

The study design will determine this. Sometimes, patients know which treatment group they are in, and sometimes it's decided randomly, like tossing a coin.

What happens after the study treatment and surgery?

You will continue to have regular check-ups and follow-up appointments with the study team to monitor your recovery and long-term health.