RightFit
RecruitingPhase 3

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares nivolumab and relatlimab plus chemotherapy with pembrolizumab plus chemotherapy to see which works better. It is for people with non-squamous non-small cell lung cancer that has spread widely (stage IV) or come back, and whose tumors have a PD-L1 protein level of at least 1%.

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must confirm the required type and stage of lung cancer.
  • You must not have had cancer treatment that works throughout the body as the main treatment for advanced or widely spread cancer.
  • A study lab must test your tumor before you are assigned treatment and find PD-L1 on at least 1% of tumor cells.
  • Your cancer must be measurable on a CT or MRI scan using the study's rules.
  • You must be fully active or able to do light work despite limits on hard physical activity.
  • You must be expected to live at least 3 months when assigned treatment.
  • Other study rules also apply.

Who can't join

  • You are pregnant or breastfeeding.
  • Your cancer has EGFR, ALK, or ROS-1 gene changes that can be treated with available targeted drugs, or these gene test results are unknown.
  • Your cancer has a BRAF V600E gene change that can be treated with available targeted drugs, an activating RET gene change, or an NTRK gene fusion. Unknown or unclear results for these genes are allowed.
  • You have untreated cancer spread to the brain or spinal cord, or cancer in the layers covering them.
  • You have another cancer that needs treatment, or an active autoimmune disease, where the immune system attacks the body.
  • You have had lung inflammation or interstitial lung disease that needed steroid pills or IV steroids, or you have had heart muscle inflammation.
  • You have had immune treatments that block PD-1, PD-L1, PD-L2, or CTLA-4, or other drugs that target the same immune-cell control systems.
  • Other study rules may exclude you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. * Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. * Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. * Participants must have a life expectancy of at least 3 months at the time of randomization. Exclusion Criteria * Participants must not be pregnant and/or breastfeeding. * Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. * Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have leptomeningeal metastases (carcinomatous meningitis). * Participants must not have concurrent malignancy requiring treatment. * Participants must not have an active autoimmune disease. * Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management. * Participants must not have a history of myocarditis. * Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (56)

AL

AZ

CA

CO

FL

ID

IL

KS

KY

MD

MI

  • Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location · Royal Oak, MI 48073Jeffrey Margolis, Site 0473 · Study contact · 000-000-0000More trials in Royal Oak

MO

MS

MT

NC

NJ

NM

NV

NY

OH

PA

TX

UT

WA