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Monoclonal Antibodies
Fianlimab + Cemiplimab 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is researching the effectiveness of two experimental drugs to treat advanced non-small cell lung cancer. It will also look at potential side effects and how it could improve quality of life.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) who haven't had prior treatments for metastatic disease, have high PD-L1 levels (≥50%), and can provide a tumor tissue sample. They should have at least one measurable lesion, good organ function, and an ECOG performance status of ≤1. Excluded are those needing significant steroid treatment recently, with certain immune conditions or untreated brain metastases.Check my eligibility
What is being tested?
The trial is testing the effectiveness of fianlimab combined with cemiplimab versus cemiplimab alone in treating NSCLC. It will also examine side effects, drug levels in blood over time, potential antibody development against the drugs, and impacts on quality of life.See study design
What are the potential side effects?
Possible side effects from taking fianlimab and cemiplimab may include reactions related to the immune system affecting various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding tendencies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Secondary outcome measures
Change from baseline in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (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
+40 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: C: cemiplimab monotherapy+placeboExperimental Treatment2 Interventions
Phase 2 and Phase 3
Group II: B: fianlimab+cemiplimabExperimental Treatment2 Interventions
Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)
Group III: A: fianlimab+cemiplimabExperimental Treatment2 Interventions
Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cemiplimab
2016
Completed Phase 2
~570
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
622 Previous Clinical Trials
379,881 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
250,564 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I haven't taken high-dose steroids for immune suppression in the last 14 days.My organs and bone marrow are working well.I can provide a tumor tissue sample that has not been treated since its collection.I am fully active and can carry on all pre-disease activities without restriction.I do not have an active autoimmune disease that needed strong medication in the last 2 years.My brain or spinal cord cancer has been treated, and I've been off steroids for 2 weeks.My tumor has EGFR mutations, ALK translocations, or ROS1 fusions.I have smoked 100 or fewer cigarettes in my lifetime.I have had lung conditions like fibrosis or inflammation not caused by infections in the past 5 years.I have a known primary immunodeficiency.I've only had certain cancer treatments before and any side effects are minimal.I have at least one tumor that can be measured on a scan.I have advanced NSCLC and haven't had treatment for its recurrent or metastatic stage.
Research Study Groups:
This trial has the following groups:- Group 1: A: fianlimab+cemiplimab
- Group 2: B: fianlimab+cemiplimab
- Group 3: C: cemiplimab monotherapy+placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of participants in this medical experiment?
"Affirmative. According to the clinicaltrials.gov website, this research is still seeking volunteers who meet its criteria; it was initially posted on June 16th 2023 and had a recent update on 12th of that same month. A total of 850 people need to be recruited from 2 locations."
Answered by AI
Are there any unoccupied positions in this research study open to volunteers?
"This clinical trial is currently enrolling participants, as indicated on the clinicaltrials.gov platform. It was initially uploaded to the website on June 16th 2023 and underwent a most recent update two days prior, on June 12th 2023."
Answered by AI
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