Active not recruitingPHASE3INTERVENTIONAL

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

This research trial is investigating a new approach to treating early-stage non-small cell lung cancer that can be surgically removed. The study aims to see if adding an immunotherapy drug, nivolumab, to standard chemotherapy before and after surgery can improve outcomes. Participants will either receive chemotherapy plus nivolumab, or chemotherapy plus a placebo (a dummy drug). After surgery, they will continue with either nivolumab or placebo. The main goal is to find out if this combination treatment can extend the time before the cancer comes back or gets worse, known as 'event-free survival'. This is a Phase 3 study, meaning it's comparing the new treatment to the best current option to see if it's more effective.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

461

Start

05 Nov 2019

Estimated completion

30 Jul 2027

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is exploring a new way to treat early-stage lung cancer, specifically a type called non-small cell lung cancer (NSCLC), which is still small enough to be removed by surgery. The main idea is to give a combination treatment both before and after the operation.

Currently, chemotherapy is often used before surgery (called 'neoadjuvant' treatment) to shrink the tumour, and sometimes after surgery ('adjuvant' treatment) to kill any remaining cancer cells. This study is adding a drug called nivolumab to this regimen. Nivolumab is an immunotherapy drug, meaning it works by helping your body's own immune system fight the cancer. Researchers want to see if adding nivolumab to chemotherapy can make the treatment more effective and help people stay cancer-free for longer.

Participants will be split into different groups. Some will receive nivolumab along with their chemotherapy, both before and after surgery. Others will receive chemotherapy with a placebo (an inactive substance that looks like nivolumab) both before and after surgery. By comparing these groups, the doctors can determine if nivolumab makes a meaningful difference in preventing the cancer from returning.

Key takeaways

Investigates a new treatment for early-stage lung cancer preventable by surgery.
Combines standard chemotherapy with the immunotherapy drug nivolumab.
Aims to improve 'event-free survival' – the time before cancer returns.
Involves treatment before and after surgery.
Comparisons are made against standard chemotherapy with a placebo.
Applicants must have no prior lung cancer treatment and specific health criteria.

Who may be eligible?

This study is looking for people with a type of lung cancer called non-small cell lung cancer, which is currently at an early stage (Stage IIA to IIIB) and can be removed by surgery. You can't have any cancer spread to your brain. It's important that you haven't had any previous treatment for your lung cancer, and you must be generally fit enough to take part, as assessed by a doctor.

There are also some reasons why you might not be able to join. For example, if you have certain existing health conditions like an active autoimmune disease, or if you have tested positive for hepatitis B, hepatitis C, or HIV. You also can't have participated in other cancer treatment studies in the past that involved similar immunotherapy drugs.

The research team will carry out a full health check and go through all the detailed requirements with you to make sure this study is right for you.

Quick self-check

Do you have early-stage non-small cell lung cancer that your doctors believe can be removed with surgery?
Have you been diagnosed with any cancer spread to your brain?
Have you had any previous treatment for your lung cancer?
Do you have an existing autoimmune disease or have tested positive for hepatitis B, C, or HIV?

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

What does participation involve?

If you decide to take part, you'll be assigned to one of the treatment groups. This will involve receiving combination treatment (chemotherapy plus nivolumab or chemotherapy plus placebo) before your surgery. After your surgery, you will continue with either nivolumab or placebo for a period. You'll need to attend regular hospital visits for assessments, blood tests, and to receive your treatment.

The medical team will carefully monitor your health and any side effects throughout the study. The total duration of your participation could span several months for active treatment and then ongoing follow-up for several years to track your long-term health and the status of your cancer. All appointments and procedures directly related to the study will be explained in detail.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments that aren't yet widely available, and close monitoring of your health by a specialist medical team. However, there are also potential risks; you might experience side effects from the study drugs, some of which could be serious. The new treatment might not work for you, or it might not be better than standard care. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (108)

Local Institution - 0104
Tampa, United States
Local Institution - 0040
Atlanta, United States
Local Institution - 0120
Augusta, United States
Local Institution - 0145
Chicago, United States
Local Institution - 0078
Chicago, United States
Local Institution - 0121
Orland Park, United States
Rcca Md Llc
Bethesda, United States
Local Institution - 0076
Boston, United States
Local Institution - 0074
Newton, United States
Local Institution - 0086
Traverse City, United States
Local Institution - 0100
Lebanon, United States
Local Institution - 0055
Cincinnati, United States

+96 more sites — see the official record for the full list.

Common questions

What is 'early stage' non-small cell lung cancer?

Early stage means the cancer is localised and hasn't spread widely, making it potentially curable with surgery. This study includes specific stages (IIA to IIIB).

What is nivolumab and how does it work?

Nivolumab is an immunotherapy drug. It helps your own immune system recognise and fight cancer cells by taking the 'brakes' off your immune response.

What is a 'placebo'?

A placebo is a substance that looks exactly like the study drug but contains no active medicine. It helps researchers understand the true effects of the active drug.

Will I know if I'm getting nivolumab or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study is complete, unless there's a medical need to find out.

What does a 'Phase 3' study mean?

A Phase 3 study is a large study that compares a new treatment with the current best treatment to see if it's more effective or has fewer side effects. It's often the last step before a drug can be approved for general use.