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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is looking into an unapproved drug (fianlimab) combined with cemiplimab and chemotherapy to see if it helps treat advanced non-small cell lung cancer more effectively than cemiplimab and chemotherapy alone.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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 review committee (BICR) using RECIST 1.1
Overall Survival (OS)
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 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 moreTrial 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
Paclitaxel
2011
Completed Phase 4
~5380
Placebo
1995
Completed Phase 3
~2670
cemiplimab
2016
Completed Phase 2
~570
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
622 Previous Clinical Trials
379,781 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
250,464 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor has EGFR mutations, ALK translocations, or ROS1 fusions.I have had lung conditions but not active lung inflammation needing strong medication in the last 5 years.I have not had systemic therapies except for some exceptions.In phase 2, patients need to have their PD-L1 expression tested by an accredited lab. In phase 3, patients need a valid PD-L1 test from a central lab.I haven't taken high doses of steroids for immune suppression recently.I am fully active and can carry on all pre-disease activities without restriction.I had immunotherapy over 6 months ago and any side effects are mild or treated.My organs and bone marrow are working well.I had platinum-based chemotherapy for my cancer and it returned more than 6 months after finishing treatment.I have a known primary immunodeficiency disorder.I have an autoimmune disease treated with immunosuppressants in the last 2 years.I have a tumor sample available that was taken before any treatment.I have at least one tumor that can be measured on a scan.My lung cancer is advanced and I haven't had treatment for its current stage.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.I have not had encephalitis, meningitis, or uncontrolled seizures in the last year.I last received anti-PD-(L)1 therapy over 12 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3 - Arm A or B
- Group 2: Phase 2 - Arm C
- Group 3: Phase 2 - Arm B
- Group 4: Phase 3 - Arm C
- Group 5: Phase 2 - Arm A
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.
Are there opportunities for enrollment in this trial at present?
"This clinical trial is actively accepting participants. The announcement was made on June 16th of this year and the posting was recently revised on June 12th, as indicated by information hosted on clinicaltrials.gov."
Answered by AI
What goals is this clinical trial attempting to accomplish?
"The 136-week long trial has multiple goals, the primary being Overall Survival (OS). Secondary aims involve monitoring adverse events that are of scientific and medical concern specific to this sponsor's product or program. Other outcomes include tracking Treatment Emergent Adverse Events (TEAEs) as well as Immune Mediated AEs (imAEs), which can be caused by uncontrolled cellular immune responses on healthy host tissues. Early detection is essential for reducing the risk of severe toxicity from drug exposure."
Answered by AI
What is the participant cap of this research endeavor?
"Affirmative. Per the clinicaltrials.gov website, this study is in its recruitment phase and was first published on June 16th 2023 with the most recent update being made on June 12th of that same year. Overall, 950 individuals need to be enrolled across 2 medical centres."
Answered by AI
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