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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am willing to undergo a biopsy before starting cemiplimab treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am considered fit for surgery to remove my tumor.
Select...
I have been diagnosed with NSCLC, HCC, or HNSCC.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in tumor-infiltrating CD8 T-cell density
Delay to surgery
Disease-free survival (DFS)
+9 moreSide effects data
From 2023 Phase 2 trial • 138 Patients • NCT0313263643%
Fatigue
37%
Diarrhoea
22%
Constipation
20%
Hypertension
17%
Arthralgia
15%
Pruritus
15%
Weight increased
13%
Pyrexia
13%
Vomiting
11%
Headache
11%
Nausea
11%
Pain in extremity
11%
Anaemia
11%
Oedema peripheral
11%
Decreased appetite
11%
Hyperglycaemia
9%
Dizziness
9%
Weight decreased
9%
Back pain
9%
Asthenia
9%
Dry skin
9%
Eczema
9%
Rash maculo-papular
9%
Hyperthyroidism
7%
Rash
7%
Abdominal pain
7%
Urinary tract infection
7%
Dyspnoea
7%
Neck pain
7%
Hypothyroidism
7%
Hypokalaemia
7%
Blood creatinine increased
7%
Blood creatine phosphokinase increased
7%
Cough
7%
Fall
7%
Haematuria
6%
Pain
6%
Alanine aminotransferase increased
6%
Muscle spasms
6%
Myalgia
6%
Upper respiratory tract infection
6%
Actinic keratosis
6%
Anxiety
6%
Basal cell carcinoma
6%
Dry mouth
6%
Infusion related reaction
4%
Influenza like illness
4%
Colitis
2%
Pancytopenia
2%
Autoimmune myocarditis
2%
Infection
2%
Clostridium difficile infection
2%
Autoimmune hepatitis
2%
Respiratory failure
2%
Urinary retention
2%
Pneumonia
2%
Pneumonitis
2%
Haemoptysis
2%
Clostridium difficile colitis
2%
Skin infection
2%
Somnolence
2%
Lymphoproliferative disorder
2%
Pneumonia staphylococcal
2%
Immune-mediated myocarditis
2%
Atypical pneumonia
2%
Autoimmune pericarditis
2%
Arthritis bacterial
2%
Hypoalbuminaemia
2%
Lymphadenopathy mediastinal
2%
Atrial fibrillation
2%
Facial paralysis
2%
Acute coronary syndrome
2%
Tibia fracture
2%
General physical health deterioration
2%
Procedural pain
2%
Pleural effusion
2%
Multiple fractures
2%
Wound haemorrhage
2%
Seborrhoeic keratosis
2%
Tumour haemorrhage
2%
Leukocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Metastatic BCC (mBCC)
Group 2: Unresectable Locally Advanced BCC (laBCC)
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
2,167 Previous Clinical Trials
3,516,340 Total Patients Enrolled
Regeneron PharmaceuticalsLead Sponsor
626 Previous Clinical Trials
381,875 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
265 Previous Clinical Trials
252,267 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never smoked or have smoked less than 100 cigarettes in my lifetime.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I am willing to undergo a biopsy before starting cemiplimab treatment.I haven't had cancer treatment or radiation in the last 6 months.My lung cancer has EGFR, ALK, or ROS1 genetic changes.My surgery for metastatic disease is not intended to cure.I am fully active or restricted in physically strenuous activity but can do light work.I have another cancer, but it's either treated or not worsening.I haven't taken steroids or immunosuppressants in the last 7 days.I am considered fit for surgery to remove my tumor.I have had lung conditions treated with steroids but not due to infection.I have been diagnosed with NSCLC, HCC, or HNSCC.I have not had major surgery in the last 14 days.My organs and bone marrow are working well.I do not have an uncontrolled HIV, HBV, or HCV infection, nor an immunodeficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B2
- Group 2: Cohort A3
- Group 3: Cohort B3
- Group 4: Cohort A1
- Group 5: Cohort A2
- Group 6: Cohort B
- Group 7: Cohort C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 upper limit for how many people can take part in this experiment?
"That is accurate. The trial was first posted on 7/23/2019 and was last edited on 11/24/2021. The study is searching for 88 patients across 1 locations."
Answered by AI
What percentage of people experience negative side effects from cemiplimab?
"While cemiplimab has shown some efficacy in prior clinical trials, it has not yet been cleared for use. Therefore, it received a score of 2."
Answered by AI
What are cemiplimab's most common indications?
"The cemiplimab medication can be used to treat alk gene mutation, malignant neoplasms, and to follow advance directives."
Answered by AI
Are new participants able to join this research project?
"Correct, this clinical trial is still open and actively recruiting patients. The listing was first posted on 7/23/2019, with the most recent update taking place on 11/24/2021."
Answered by AI
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