Actively Recruiting
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
Led by Weill Medical College of Cornell University · Updated on 2026-04-21
112
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Before surgery to remove their lung cancer, participants will take: 1. Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR 2. Cemiplimab every 3 weeks for up to 3 doses with SBRT (Arm B). SBRT will be given on day 1 before taking cemiplimab, then SBRT alone on day 2 and day 3. Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.
CONDITIONS
Official Title
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years with histologically or cytologically confirmed clinical stages IB (T2aN0), II, and III (N2) NSCLC eligible for surgery
- Patients with measurable disease according to RECIST v1.1
- Known PD-L1 expression
- No known EGFR mutations or ALK fusions
- ECOG performance status of 0 or 1
- No prior therapy for lung cancer
- Adequate organ and bone marrow function including ANC ≥ 1.5 x10^3/uL, platelets ≥ 75 x10^3/uL, hemoglobin ≥ 9 g/dL, serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 50 ml/min, bilirubin ≤1.5 x ULN (or ≤3 x ULN with Gilbert's Syndrome), AST/ALT ≤3 x ULN
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and agree to use effective contraception during the study and for 6 months after last treatment
- Male participants with WOCBP partners must use condoms or practice sexual abstinence unless vasectomized
- WOCBP must agree not to donate eggs during the study and for 6 months after last treatment
- All men must agree not to donate sperm during the study and for 6 months after last treatment
- Written informed consent obtained
You will not qualify if you...
- History of other primary malignancies except those treated curatively with no active disease for 2 or more years and low recurrence risk
- Current or recent use of immunosuppressive medication within 14 days before first dose, except certain steroids and local treatments
- Ongoing corticosteroid therapy over 10 mg prednisone daily within 1 week prior to study drug start
- Active or prior autoimmune or inflammatory disorders requiring systemic treatment, with some exceptions such as vitiligo or stable hypothyroidism
- Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, or psychiatric/social conditions limiting compliance
- Interstitial lung disease or active noninfectious pneumonitis requiring immunosuppressive treatment
- Receipt of live vaccines within 30 days before study start
- Prior allogeneic stem cell or solid organ transplant
- Uncontrolled HIV, active hepatitis B or C, immunodeficiency, or tuberculosis
- Pregnant or breastfeeding women
- Sexually active men and WOCBP unwilling to use highly effective contraception during and for 6 months after study
- Significant cardiovascular disease (heart failure class II-IV, recent myocardial infarction, or stroke within 1 year)
- Known hypersensitivity to study drugs or excipients
- Infection requiring hospitalization or IV treatment within 2 weeks before study drug start
AI-Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
J
Julissa Murillo
CONTACT
J
Julia Muuse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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