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A Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy in Participants with Non-squamous Stage IV or Recurrent NSCLC and PD-L1 ≥1%
EU CTIS ID: 2024-513682-40-01
What this study is testing
The main goal of this study is to see if nivolumab+relatlimab FDC (1:1) + chemotherapy allows people to live longer (Overall Survival or OS) than pembrolizumab + chemotherapy for people who have a certain type of lung cancer that has either spread to other parts of the body (Stage IV) or come back after treatment (recurrent).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The people who can participate in this study are men and women who are 18 years or older.
- They must have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either in stage IV or has come back.
- This type of cancer has not been treated with any other cancer drugs before.
- The cancer cells must have a certain amount of a protein called PD-L1, which will be checked in a lab before the study starts.
- The cancer must be visible on a CT or MRI scan, and these scans must be done within 32 days before receiving study treatment.
- The participants should be generally healthy, with a score of 1 or less on a scale that measures how well they can do their daily activities.
You likely can't join if
- Women who are pregnant or breastfeeding.
- People who have certain changes in their cancer cells that can be treated with other drugs are also not allowed. Tests are required to determine changes in the EGFR, ALK, ROS-1, and BRAF genes.
- Patients with known changes in BRAF, RET and NTRK cannot participate.
- People with cancer that has spread to the brain or the lining of the brain and spinal cord cannot participate.
- People with another type of cancer that needs treatment, or people with diseases where the body's immune system attacks its own cells, are also not allowed.
- People who have been treated with certain drugs that affect the immune system, or who have had a heart condition called myocarditis, cannot participate.
See the full eligibility criteria
- The people who can participate in this study are men and women who are 18 years or older.
- They must have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either in stage IV or has come back.
- This type of cancer has not been treated with any other cancer drugs before.
- The cancer cells must have a certain amount of a protein called PD-L1, which will be checked in a lab before the study starts.
- The cancer must be visible on a CT or MRI scan, and these scans must be done within 32 days before receiving study treatment.
- The participants should be generally healthy, with a score of 1 or less on a scale that measures how well they can do their daily activities.
- They should also be expected to live for at least 3 months from the start of the study.
- Women who are pregnant or breastfeeding.
- People who have certain changes in their cancer cells that can be treated with other drugs are also not allowed. Tests are required to determine changes in the EGFR, ALK, ROS-1, and BRAF genes.
- Patients with known changes in BRAF, RET and NTRK cannot participate.
- People with cancer that has spread to the brain or the lining of the brain and spinal cord cannot participate.
- People with another type of cancer that needs treatment, or people with diseases where the body's immune system attacks its own cells, are also not allowed.
- People who have been treated with certain drugs that affect the immune system, or who have had a heart condition called myocarditis, cannot participate.
The study team makes the final eligibility decision.
Where it's taking place
- India
- Argentina
- Japan
- Saudi Arabia
- Mexico
- Taiwan
- Brazil
- Switzerland
- United Kingdom
- Colombia
- Korea, Republic of
- Australia
- United States
- Turkey
- Chile
- China
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Argentina; Japan; Saudi Arabia; Mexico; Taiwan and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.