← Back to Search

Monoclonal Antibodies

Fianlimab + Cemiplimab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2 & 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample, without intervening therapy between biopsy collection and screening as described in the protocol
Must not have
Patients with tumors tested positive for actionable estimated glomerular filtration rate (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS oncogene 1 (ROS1) fusions, as described in the protocol.
History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new drug called fianlimab with cemiplimab and chemotherapy in patients with advanced lung cancer. The goal is to see if this combination is more effective than current treatments. The new drugs help the immune system fight cancer, while chemotherapy attacks the cancer cells directly.

Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) who haven't had systemic treatment for recurrent or metastatic NSCLC. They must have a performance status ≤1, indicating they are relatively active and can care for themselves. Participants need to have measurable lung cancer lesions and adequate organ function. Those with certain gene mutations, recent immune suppression treatments, untreated brain metastases, significant autoimmune disease, or prior specific therapies are excluded.
What is being tested?
The trial is testing the effectiveness of fianlimab combined with cemiplimab and chemotherapy versus just cemiplimab and chemotherapy in treating advanced NSCLC. It will also examine side effects, drug levels in blood over time, potential antibody development against the drugs, and any impact on quality of life.
What are the potential side effects?
Potential side effects include reactions related to the immune system affecting various organs which could lead to inflammation issues; infusion-related reactions during administration; fatigue; digestive problems like nausea or diarrhea; changes in blood counts leading to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I have a tumor sample available that was taken before any treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My tumor has EGFR mutations, ALK translocations, or ROS1 fusions.
Select...
I have had lung conditions but not active lung inflammation needing strong medication in the last 5 years.
Select...
I have a known primary immunodeficiency disorder.
Select...
I have an autoimmune disease treated with immunosuppressants in the last 2 years.
Select...
I don't have active brain tumors or untreated spinal issues, or they've been treated and I've been stable for 2 weeks without steroids.
Select...
I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1
Overall Survival (OS)
Secondary study objectives
Change from baseline in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Change from baseline in patient-reported cough per EORTC QLQ-LC13
Change from baseline in patient-reported dyspnea per EORTC QLQ-LC13
+36 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 3 - Arm CExperimental Treatment6 Interventions
Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo
Group II: Phase 3 - Arm A or BExperimental Treatment6 Interventions
Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy
Group III: Phase 2 - Arm CExperimental Treatment6 Interventions
Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo
Group IV: Phase 2 - Arm BExperimental Treatment6 Interventions
Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy
Group V: Phase 2 - Arm AExperimental Treatment6 Interventions
Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
cemiplimab
2016
Completed Phase 2
~910
Pemetrexed
2014
Completed Phase 3
~5550
Paclitaxel
2011
Completed Phase 4
~5810
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and chemotherapy. Immune checkpoint inhibitors, such as Cemiplimab (an anti-PD-1 monoclonal antibody) and investigational drugs like Fianlimab (an anti-LAG-3 monoclonal antibody), work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Chemotherapy involves cytotoxic agents like paclitaxel and carboplatin, which kill rapidly dividing cancer cells by interfering with their DNA replication. These treatments are crucial for NSCLC patients as they can improve survival rates and quality of life by targeting cancer cells through different mechanisms, potentially leading to more effective and comprehensive cancer control.
Comparative Efficacy and Safety of Anti-PD-1/PD-L1 for the Treatment of Non-Small Cell Lung Cancer: A Network Meta-Analysis of 13 Randomized Controlled Studies.Cetuximab and other anti-epidermal growth factor receptor monoclonal antibodies in the treatment of non-small cell lung cancer.

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
658 Previous Clinical Trials
384,679 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
280 Previous Clinical Trials
253,905 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05800015 — Phase 2 & 3
Non-Small Cell Lung Cancer Research Study Groups: Phase 3 - Arm A or B, Phase 2 - Arm C, Phase 2 - Arm B, Phase 3 - Arm C, Phase 2 - Arm A
Non-Small Cell Lung Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05800015 — Phase 2 & 3
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05800015 — Phase 2 & 3
~633 spots leftby Jan 2030