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Monoclonal Antibodies

Neoadjuvant Cemiplimab for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be willing and able to have excisional or core needle biopsies of tumor prior to initiation of cemiplimab as defined in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
NSCLC cohorts only: Patients do not have a history of smoking. History of smoking is defined as smoking ≥100 cigarettes in a lifetime.
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months following surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is effective at treating three different types of cancer.

Who is the study for?
Adults with resectable Non-Small Cell Lung Cancer (NSCLC), Liver Cancer (HCC), or Head and Neck Squamous Cell Carcinoma (HNSCC) who are in good health, have no major surgeries recently, aren't on immunosuppressants, and haven't had recent cancer treatments. NSCLC patients must be non-smokers without certain gene mutations.
What is being tested?
The trial is testing cemiplimab alone and combined with fianlimab before surgery to see if they shrink tumors safely. Both drugs are monoclonal antibodies; cemiplimab targets PD-1 receptors while fianlimab blocks LAG-3 proteins involved in cancer.
What are the potential side effects?
Possible side effects include immune reactions leading to inflammation in various organs, infusion-related reactions like fever or chills, fatigue, potential for infections due to weakened immunity, and possibly other unknown risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to undergo a biopsy before starting cemiplimab treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am considered fit for surgery to remove my tumor.
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I have been diagnosed with NSCLC, HCC, or HNSCC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never smoked or have smoked less than 100 cigarettes in my lifetime.
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I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.
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I haven't had cancer treatment or radiation in the last 6 months.
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My lung cancer has EGFR, ALK, or ROS1 genetic changes.
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My surgery for metastatic disease is not intended to cure.
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I do not have an uncontrolled HIV, HBV, or HCV infection, nor an immunodeficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major pathologic response (MPR) at time of surgery for the NSCLC cohorts
Major treatment effect (MTE) at time of surgery is the primary endpoint for the HNSCC cohort
Significant tumor necrosis (STN) at time of surgery is the primary endpoint for the HCC cohorts
Secondary study objectives
Change in tumor-infiltrating CD8 T-cell density
Delay to surgery
Disease-free survival (DFS)
+7 more

Side effects data

From 2023 Phase 2 trial • 138 Patients • NCT03132636
44%
Fatigue
37%
Diarrhoea
22%
Constipation
22%
Hypertension
17%
Arthralgia
15%
Pruritus
15%
Weight increased
13%
Pyrexia
13%
Oedema peripheral
13%
Vomiting
13%
Headache
11%
Hyperglycaemia
11%
Decreased appetite
11%
Nausea
11%
Anaemia
9%
Hyperthyroidism
9%
Asthenia
9%
Pain in extremity
9%
Dry skin
9%
Dizziness
9%
Eczema
9%
Back pain
9%
Rash maculo-papular
9%
Myalgia
9%
Weight decreased
7%
Rash
7%
Hypothyroidism
7%
Abdominal pain
7%
Urinary tract infection
7%
Neck pain
7%
Hypokalaemia
7%
Fall
7%
Dry mouth
7%
Haematuria
7%
Blood creatinine increased
7%
Dyspnoea
7%
Cough
7%
Blood creatine phosphokinase increased
6%
Pain
6%
Upper respiratory tract infection
6%
Anxiety
6%
Muscle spasms
6%
Infusion related reaction
6%
Alanine aminotransferase increased
6%
Basal cell carcinoma
6%
Paraesthesia
6%
Actinic keratosis
4%
Colitis
4%
Atrial fibrillation
4%
Influenza like illness
2%
Myocardial infarction
2%
General physical health deterioration
2%
Erysipelas
2%
Haemoptysis
2%
Immune-mediated myocarditis
2%
Lymphadenopathy mediastinal
2%
Lymphoproliferative disorder
2%
Arthritis bacterial
2%
Leukocytosis
2%
Infection
2%
Skin infection
2%
Deep vein thrombosis
2%
Facial paralysis
2%
Atypical pneumonia
2%
Pulmonary embolism
2%
Pleural effusion
2%
Autoimmune myocarditis
2%
Clostridium difficile infection
2%
Procedural pain
2%
Urinary retention
2%
Respiratory failure
2%
Tibia fracture
2%
Pneumonia staphylococcal
2%
Seborrhoeic keratosis
2%
Autoimmune pericarditis
2%
Hypoalbuminaemia
2%
Clostridium difficile colitis
2%
Autoimmune hepatitis
2%
Somnolence
2%
Acute coronary syndrome
2%
Multiple fractures
2%
Wound haemorrhage
2%
Pancytopenia
2%
Pneumonitis
2%
Pneumonia
2%
Tumour haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Metastatic BCC (mBCC)
Group 2: Unresectable Locally Advanced BCC (laBCC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment1 Intervention
Cemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual
Group II: Cohort B3Experimental Treatment2 Interventions
Cemiplimab and fianlimab before and after surgery (HCC)
Group III: Cohort B2Experimental Treatment1 Intervention
SBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC)
Group IV: Cohort BExperimental Treatment1 Intervention
Cemiplimab prior to surgery; cemiplimab post surgery (HCC)
Group V: Cohort A3Experimental Treatment2 Interventions
Platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Group VI: Cohort A2Experimental Treatment2 Interventions
Cemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Group VII: Cohort A1Experimental Treatment2 Interventions
Cemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cemiplimab
2016
Completed Phase 2
~910

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,693 Total Patients Enrolled
Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
386,429 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
255,270 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03916627 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Cohort B3, Cohort B2, Cohort A3, Cohort A1, Cohort A2, Cohort B, Cohort C
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT03916627 — Phase 2
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03916627 — Phase 2
~6 spots leftby Jun 2025
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