Active not recruitingPHASE2INTERVENTIONAL

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

This research study is for people with advanced non-small cell lung cancer, either Stage IV or cancer that has come back. Doctors want to see if combining two new treatments, relatlimab and nivolumab, with standard chemotherapy (carboplatin, cisplatin, paclitaxel, nab-paclitaxel, or pemetrexed) works better than nivolumab plus chemotherapy alone. The main goals are to check how safe these drug combinations are and to find out if the three-drug combination (relatlimab, nivolumab, and chemotherapy) leads to more people responding to treatment compared to the two-drug combination (nivolumab and chemotherapy). This is a Phase 2 study, meaning it's still in the earlier stages of testing these new approaches. Participation is open to adults aged 18 and over, of any sex, who meet specific health requirements.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

468

Start

17 Feb 2021

Estimated completion

27 Feb 2026

Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer

What is this study about?

This study is looking into new ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer is quite advanced (Stage IV) or has come back after previous treatments. The researchers want to find out if using a combination of medicines works better than current treatments.

You might be offered one of two treatment combinations. Both combinations include chemotherapy, which is a common cancer treatment. One group will receive nivolumab plus chemotherapy. The other group will receive two new drugs, relatlimab and nivolumab, alongside chemotherapy. All these drugs work in different ways to fight cancer.

The main aims of this study are to see how safe these combinations are and to check if adding relatlimab to nivolumab and chemotherapy helps more people respond to treatment. This means doctors will be looking to see if the cancer shrinks or stops growing. By comparing the two groups, they hope to identify the most effective and safest treatment option for people with this type of lung cancer.

Key takeaways

Tests new drug combinations for advanced lung cancer.
Compares two immune-boosting drugs plus chemotherapy against one immune-boosting drug plus chemotherapy.
Aims to check safety and how well the treatments shrink or control cancer.
For adults 18+ with Stage IV or recurrent non-small cell lung cancer.
Participation involves regular clinic visits, tests, and treatment with follow-up.

Who may be eligible?

To join this study, you need to have non-small cell lung cancer that is either Stage IV (meaning it has spread) or has come back after you've had treatment for it before. Doctors will need to confirm this with a special test called a biopsy, and they'll check if your cancer is of a specific type (squamous or non-squamous).

Your general health and ability to perform daily activities must be good. This is measured by something called an ECOG score, and you need to have a score of 1 or less. The doctors also need to be able to measure your cancer, usually with scans like CT or MRI, to see how it responds to treatment. You must not have had any previous drug treatments for your advanced or spread lung cancer.

There are also some reasons why you might not be able to join. For example, if your cancer has specific genetic changes (like EGFR, ALK, ROS-1, or BRAF V600E) that can be treated with other targeted drugs, this study might not be suitable for you. Also, if the cancer has spread to your brain lining or is in your brain in a way that hasn't been treated, you wouldn't be able to join. If you've had other cancers recently or have been treated with similar immune-boosting drugs in the past, you also wouldn't be eligible.

Quick self-check

Do you have non-small cell lung cancer that is Stage IV or has recurred?
Are you generally well and able to carry out your daily activities comfortably?
Have you not received any drug treatments for your advanced lung cancer yet?
Do your doctors believe your cancer can be measured with scans?

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 in this study, you will have regular visits to the clinic. During these visits, doctors will perform various assessments, including physical exams, blood tests, and scans (like CT or MRI) to monitor your health and how your cancer is responding to the treatment. You will receive the study drugs according to a specific schedule, which will be explained to you in detail. The exact number of visits, tests, and how long you will receive treatment will depend on your individual response and the study's plan. After your treatment phase, there will be a period of follow-up visits to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation could be several months or longer, depending on your health and treatment response.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and receiving close medical attention. However, there are also potential risks, as the study drugs can have side effects, some of which may be serious. The research team will explain all known side effects and help manage any you experience. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (125)

Local Institution - 0160
Duarte, United States
Local Institution - 0081
Orange, United States
Local Institution - 0139
New Haven, United States
Local Institution - 0153
Jacksonville, United States
Local Institution - 0011
Port Saint Lucie, United States
Local Institution - 0089
Athens, United States
Local Institution - 0121
Wichita, United States
Local Institution - 0159
Lexington, United States
Local Institution - 0002
Louisville, United States
Local Institution - 0082
Scarborough, United States
Local Institution - 0129
Omaha, United States
Local Institution - 0152
Howell Township, United States

+113 more sites — see the official record for the full list.

Common questions

What type of lung cancer is this study for?

This study is for people with advanced non-small cell lung cancer (Stage IV) or cancer that has returned after previous treatments.

What drugs are being tested?

The study is testing combinations including nivolumab and chemotherapy, and for some, also relatlimab, which are new immune-boosting drugs.

Will I definitely get the new drug combination?

This is a randomised study, meaning you will be randomly assigned to receive one of the two treatment combinations.

What is the main goal of the study?

The main goals are to check how safe the drug combinations are and to see if adding relatlimab improves how well people respond to treatment.

How long does participation last?

The length of your participation will depend on your individual health and how you respond to the treatment, but it will involve ongoing assessment and follow-up.