Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
This study tests two different approaches to treat early-stage non-small cell lung cancer before surgery: one combining an immunotherapy drug (Cemiplimab) with chemotherapy, and another combining Cemiplimab with radiation therapy. The goal is to determine which approach works better at shrinking tumors and improving outcomes for patients with stage IB, II, or III lung cancer.
Key Objective:This trial is testing whether combining immunotherapy with either chemotherapy or radiation before surgery can improve cancer control and survival in patients with non-small cell lung cancer.
Who to Consider:Patients with newly diagnosed stage IB, II, or stage III non-small cell lung cancer who are candidates for surgery should consider this trial.
Trial Parameters
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Brief 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 Criteria
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 status of 0 or 1. 8. No prior therapy for lung cancer 9. Adequate organ and bone marrow function as defined below: * Absolute neutrophil count (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 doc