BridgeMD
A Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy in Participants with Stage IV or Recurrent NSCLC
EU CTIS ID: 2023-508372-10-00
What this study is testing
Part 1 To evaluate the proportion of participants with TRAEs leading to discontinuation within 12 weeks after the first dose of nivolumab plus 2 different dose levels of relatlimab (360 mg and 720 mg) in combination with PDCT in dose safety evaluable participants with histologically confirmed 1L Stage IV or recurrent NSCLC Part 2 To evaluate ORR of nivolumab plus relatlimab in combination with PDCT relative to nivolumab in combination with PDCT in participants with histologically confirmed 1L Stage IV or recurrent NSCLC
- Therapeutic exploratory (Phase II)
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
- Males and females; ≥ 18 years of age or local age of majority.
- Histologically confirmed metastatic NSCLC of squamous (SQ) or nonsquamous (NSQ) histology with Stage IV or recurrent disease following multi-modal therapy for locally advanced disease.
- Measurable disease by computed tomography or magnetic resonance imaging per Response
- Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization.
- No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
- ECOG PS of less than or equal to 1 at screening and confirmed prior to randomization.
You likely can't join if
- Women who are pregnant or breastfeeding.
- Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to available targeted inhibitor therapy. All participants with NSQ histology must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ histology and unknown EGFR, ALK, or ROS-1 status are excluded.
- Participants with known BRAFV600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
- Participants with untreated central nervous system metastases.
- Participants with leptomeningeal metastases (carcinomatous meningitis).
- Concurrent malignancy requiring treatment.
See the full eligibility criteria
- Males and females; ≥ 18 years of age or local age of majority.
- Histologically confirmed metastatic NSCLC of squamous (SQ) or nonsquamous (NSQ) histology with Stage IV or recurrent disease following multi-modal therapy for locally advanced disease.
- Measurable disease by computed tomography or magnetic resonance imaging per Response
- Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization.
- No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
- ECOG PS of less than or equal to 1 at screening and confirmed prior to randomization.
- Participants must have a life expectancy of at least 3 months at the time of first dose.
- A formalin-fixed paraffin-embedded tissue block containing enough tissue to cut 20 sections (preferred) or a minimum of 20 unstained slides of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or surgical specimen obtained during screening or prior to enrollment (within 3 months of enrollment if stored at 2-8°C or within 2 months of enrollment if stored at ambient temperature and with no intervening systemic anti-cancer treatment between time of acquisition and enrollment) must be sent to the central laboratory.
- Participants must have PD-L1 immunohistochemistry (IHC) results from a central laboratory during the screening period prior to randomization.
- Women who are pregnant or breastfeeding.
- Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to available targeted inhibitor therapy. All participants with NSQ histology must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ histology and unknown EGFR, ALK, or ROS-1 status are excluded.
- Participants with known BRAFV600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
- Participants with untreated central nervous system metastases.
- Participants with leptomeningeal metastases (carcinomatous meningitis).
- Concurrent malignancy requiring treatment.
- Participants with an active, known, or suspected autoimmune disease.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Participants with history of myocarditis.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Switzerland
- United States
- Chile
- Argentina
- Australia
- Mexico
- United Kingdom
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 Brazil; Switzerland; United States; Chile; Argentina; Australia and 2 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.