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Checkpoint Inhibitor
Sarilumab + Cemiplimab for Lung Cancer
Phase 1
Recruiting
Led By Xiuning Le, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed non-squamous, non-small cell lung cancer locally advanced or metastatic disease.
For Cohort A: NSCLC which harbours EGFR Exon 19 deletion, EGFR L858R mutation, or activating EGFR exon20 insertion or exon 18/21 atypical mutations. EGFR mutation status must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 2 years
Awards & highlights
Study Summary
This trial tests if a combo of drugs can help people with EGFR or LKB1/STK11-mutant NSCLC.
Who is the study for?
Adults over 18 with advanced non-squamous, non-small cell lung cancer (NSCLC) and specific mutations (EGFR or LKB1). They may have had up to three prior treatments but must not be pregnant, breastfeeding, or have severe diseases. Participants need functioning major organs and no recent surgeries. Men and women must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two drugs: Sarilumab (Kevzara) and Cemiplimab for NSCLC patients with certain genetic mutations. It aims to control the disease by using these medications together in participants who meet specific genetic criteria.See study design
What are the potential side effects?
Potential side effects include reactions at injection sites, increased risk of infections due to immune system suppression, possible organ inflammation, fatigue, digestive issues like diarrhea or constipation, liver problems indicated by blood tests changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced or has spread and is not squamous cell type.
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My NSCLC has specific EGFR mutations confirmed by a certified test.
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I have taken EGFR TKI treatment for my condition.
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I have a measurable tumor that has not been treated with radiation.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: LKB1-mutant cohortExperimental Treatment2 Interventions
Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B.
Group II: Cohort A : EGFR-mutant cohortExperimental Treatment2 Interventions
Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,420 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
622 Previous Clinical Trials
380,675 Total Patients Enrolled
Xiuning Le, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father children and will use birth control during and 3 months after the study.I have skin ulcers that are healing or not yet healed.My NSCLC has specific EGFR mutations confirmed by a certified test.I have not received a live vaccine in the last 3 months.I do not have serious heart issues like severe heart failure or uncontrolled heart rhythm problems.My brain or spinal tumors have been stable or without symptoms for 2 weeks.I have a measurable tumor that has not been treated with radiation.I don't have severe side effects from past treatments, except for possible hair loss.I have not had cancer, except for specific skin cancers or cervical carcinoma in-situ, in the last 5 years.I have taken EGFR TKI treatment for my condition.My NSCLC has an LKB1 mutation confirmed by a certified test.My lung cancer is advanced or has spread and is not squamous cell type.I have been in close contact with someone who has TB.I have a history of severe gut issues, including inflammatory bowel disease or severe diverticulitis.I do not have any severe or uncontrolled illnesses.I have had an infection in a joint or around a joint implant before.You have a positive test for hepatitis C antibodies.I have cognitive impairments.I have had serious infections like histoplasmosis or candidiasis in the past.I have had up to 3 treatments with chemotherapy or immunotherapy.You have a serious autoimmune condition like rheumatoid arthritis.I have not had surgery in the last 4 weeks and do not plan to during the study.I have tested positive for hepatitis B.You have tested positive for HIV or are suspected to have HIV.I have had shingles more than once or currently have it.I am not breastfeeding, have a negative pregnancy test, and will use contraception during and after the study.I do not have active TB nor a history of incompletely treated TB.I am 18 years old or older.You had a severe allergic reaction to a biologic drug in the past, or you are allergic to any part of the sarilumab product.My diabetes is not under control, with an HbA1c over 9%.I am fully active or can carry out light work.I haven't had a fever or needed treatment for infections in the last 4 weeks.My cancer has specific EGFR mutations and I've been treated with osimertinib, unless medically advised otherwise.My blood, liver, and kidney functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A : EGFR-mutant cohort
- Group 2: Cohort B: LKB1-mutant cohort
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.
Has the EGFR-mutant cohort of Cohort A gained regulatory approval?
"Due to the limited information regarding Cohort A: EGFR-mutant cohort's efficacy and safety, our assessment of its risk profile was low at a score of 1."
Answered by AI
Are there still vacancies available to participate in this research?
"As indicated on clinicaltrials.gov, this medical trial is no longer accepting applications. It was originally posted in July 31st 2023 and last updated on January 19th 2023; however, 1587 other trials are currently enrolling participants at the moment."
Answered by AI
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