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Checkpoint Inhibitor
Radioimmunotherapy vs Chemoimmunotherapy for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Nasser K Altorki, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ and bone marrow function as defined below: ANC ≥1.5 x10(3)/uL, Platelets ≥75 x10(3)/uL, Hemoglobin ≥9 g/dL, Serum creatinine ≤1.5 X upper limit of normal (ULN) OR calculated CrCl ≥50 ml/min (using the Cockcroft-Gault formula), Serum total bilirubin ≤1.5 X ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted, Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ≤3 X ULN
No known EGFR mutations or ALK fusions.
Must not have
Uncontrolled, intercurrent illness including ongoing or active infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Interstitial lung disease or active, noninfectious pneumonitis that requires immune-suppressive doses of glucocorticoids to assist with management
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if using Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) can effectively treat stages IB, II, and
Who is the study for?
This trial is for individuals with stages IB, II, and III (N2) Non-Small Cell Lung Cancer who are planning to have surgery. Participants must be fit for both chemotherapy and immunotherapy. They cannot join if they've had previous treatments for NSCLC or have certain medical conditions that the study outlines.
What is being tested?
The trial tests two pre-surgery treatments: Cemiplimab combined with platinum-based chemotherapy (Arm A), or Cemiplimab with stereotactic body radiation therapy (SBRT) (Arm B). After surgery, participants in both groups will continue to receive Cemiplimab for one year.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as skin issues, hormone gland problems, inflammation of organs like lungs or intestines; fatigue from radiation; and typical chemo side effects like nausea, hair loss, and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer does not have EGFR mutations or ALK fusions.
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My cancer has been tested for PD-L1 expression.
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I am older than 18 years.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have not received any treatment for lung cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled illnesses or infections that require antibiotics.
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I have a lung condition treated with high-dose steroids.
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I do not have HIV, hepatitis B, or hepatitis C.
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I have had a stem cell or organ transplant in the past.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with pathological complete response (pCR)
Secondary study objectives
Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30)
Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-LC13)
Change in number of participants with distant recurrence
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cemiplimab with chemotherapy (Arm A)Experimental Treatment2 Interventions
Before lung cancer surgery:
1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles.
2. Platinum-based chemotherapy intravenously every 3 weeks up to 3 cycles.
After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments).
Group II: Cemiplimab with SBRT (Arm B)Experimental Treatment2 Interventions
Before lung cancer surgery:
1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles.
2. SBRT on days 1, 2, and 3.
After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1450
Stereotactic body radiation therapy
2017
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,079 Previous Clinical Trials
1,137,787 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
658 Previous Clinical Trials
385,517 Total Patients Enrolled
Nasser K Altorki, MDPrincipal InvestigatorWeill Medical College of Cornell University
4 Previous Clinical Trials
114 Total Patients Enrolled
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