Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer
Weill Medical College of Cornell University
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for surgical resection with curative intent. Patients with 2 synchronous NSCLC are allowed. 2. Measurable disease, as defined by RECIST v1.1. 3. Known PD-L1 expression. 4. No known EGFR mutations or ALK fusions. 5. Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures. 6. Age \> 18 years at time of study entry. 7. Eastern Cooperative Oncology Group (ECOG) performance statu…
Interventions
- DrugCemiplimab
Intravenously
- DrugPlatinum based chemotherapy
Intravenously
- RadiationStereotactic body radiation therapy
8 Gy times 3 treatment days (Days 1-3)
Location
- Weill Cornell MedicineNew York, New York