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Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer
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.
Details
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 112 |
| Start date | 2025-02-21 |
| Completion | 2032-01 |
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- Cemiplimab
- Platinum based chemotherapy
- Stereotactic body radiation therapy
Primary outcomes
- Number of participants with pathological complete response (pCR) — Surgical resection (Weeks 9-13).
pCR is defined as the absence of viable tumor in the tumor bed and the draining lymph nodes upon pathological review of the tissue.
Countries
United States